The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Pelvic C-clamp.
Device ID | K922796 |
510k Number | K922796 |
Device Name: | PELVIC C-CLAMP |
Classification | Component, Traction, Invasive |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Diane Cochet-wynant |
Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-09 |
Decision Date | 1994-03-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679398370 | K922796 | 000 |