Calcifill_510K_Final

Calcifill_510K_Final - Submitted June 11 th 2008 J&S...

Info iconThis preview shows pages 1–3. Sign up to view the full content.

View Full Document Right Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: Submitted June 11 th 2008 J&S Bones Calcifill School of Biomedical Engineering, Science and Health Systems BMES 680: Product Development for Medical Applications 510(k) Premarket Notification CALCIFILL -2- Table of Contents I. PRODUCT INTRODUCTION .......................................................................................................................... 3 II. DEVICE DESCRIPTION ................................................................................................................................. 3 Intended Use .................................................................................................................................................. 3 Material Properties .......................................................................................................................................... 3 Package Content ............................................................................................................................................ 4 Principles of Operations .................................................................................................................................. 4 Safety Indications: .......................................................................................................................................... 4 Performance Indications: ................................................................................................................................ 4 III. SUBSTANTIAL EQUIVALENCE .................................................................................................................. 4 IV. PRODUCT DEVELOPMENT ....................................................................................................................... 6 4.1 PROCESS PLANNING .............................................................................................................................. 6 4.2 REQUIREMENTS SPECIFICATIONS ........................................................................................................ 7 4.3 DESIGN SPECIFICATIONS ...................................................................................................................... 7 Chemical Specifications of Calcifill ............................................................................................................... 7 Type I Bovine Collagen Specifications ............................................................................................................ 7 Physical Specifications of Calcifill ................................................................................................................. 8 4.4 HAZARD/RISK ANALYSIS ...................................................................................................................... 8 4.5 VERIFICATION AND VALIDATION ...................................................................................................... 10 Chemical and performance verification test plan ........................................................................................... 10Chemical and performance verification test plan ....
View Full Document

This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

Page1 / 13

Calcifill_510K_Final - Submitted June 11 th 2008 J&S...

This preview shows document pages 1 - 3. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online