The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Incision And Drainage Trays.
Device ID | K931597 |
510k Number | K931597 |
Device Name: | CARAPACE INCISION AND DRAINAGE TRAYS |
Classification | Suture Removal Kit |
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 | MCZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-01 |
Decision Date | 1993-11-05 |