The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Dressing Change Tray-medium.
| Device ID | K802954 |
| 510k Number | K802954 |
| Device Name: | DRESSING CHANGE TRAY-MEDIUM |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-20 |
| Decision Date | 1980-12-17 |