The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Ampco Dressing Change Trays.
| Device ID | K801333 |
| 510k Number | K801333 |
| Device Name: | AMPCO DRESSING CHANGE TRAYS |
| Classification | Wrap, Sterilization |
| Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-03 |
| Decision Date | 1980-08-22 |