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 |