The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cranial Spring Clip (csc).
Device ID | K974206 |
510k Number | K974206 |
Device Name: | SYNTHES CRANIAL SPRING CLIP (CSC) |
Classification | Plate, Cranioplasty, Preformed, Alterable |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri Musgnung |
Correspondent | Sheri Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | GWO |
CFR Regulation Number | 882.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-10 |
Decision Date | 1998-03-16 |
Summary: | summary |