The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Control Cable System.
| Device ID | K934557 |
| 510k Number | K934557 |
| Device Name: | CONTROL CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-16 |
| Decision Date | 1994-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295067788 | K934557 | 000 |
| 10603295067771 | K934557 | 000 |