The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Angiography Trays.
Device ID | K931629 |
510k Number | K931629 |
Device Name: | CARAPACE ANGIOGRAPHY TRAYS |
Classification | Catheter, Intravascular, Diagnostic |
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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-02 |
Decision Date | 1993-12-06 |