The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Ampco-dressing Change Tray-major Dc.
| Device ID | K802964 |
| 510k Number | K802964 |
| Device Name: | AMPCO-DRESSING CHANGE TRAY-MAJOR DC |
| Classification | Tray, Surgical, Instrument |
| Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 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 | 1980-11-21 |
| Decision Date | 1981-01-05 |