The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Various Disposable Kits/trays/instru.
Device ID | K840976 |
510k Number | K840976 |
Device Name: | VARIOUS DISPOSABLE KITS/TRAYS/INSTRU |
Classification | Tray, Surgical, Instrument |
Applicant | CARAPACE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-06 |
Decision Date | 1984-05-31 |