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 |