The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Smf Resorbable Meshes And Sheets.
Device ID | K003786 |
510k Number | K003786 |
Device Name: | SMF RESORBABLE MESHES AND SHEETS |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Thomas M Maguire |
Correspondent | Thomas M Maguire SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-08 |
Decision Date | 2001-02-27 |