The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Debridement Kits.
Device ID | K931669 |
510k Number | K931669 |
Device Name: | CARAPACE DEBRIDEMENT KITS |
Classification | Wrap, Sterilization |
Applicant | CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
Contact | Jerry W Myers |
Correspondent | Jerry W Myers CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-06 |
Decision Date | 1994-02-07 |