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 |