The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Resorbable Cranial Clamps.
Device ID | K021408 |
510k Number | K021408 |
Device Name: | RESORBABLE CRANIAL CLAMPS |
Classification | Cover, Burr Hole |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Matthew M Hull |
Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | GXR |
CFR Regulation Number | 882.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-03 |
Decision Date | 2002-07-29 |
Summary: | summary |