The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Ampco Kidney Dialysis Tray.
| Device ID | K823839 |
| 510k Number | K823839 |
| Device Name: | AMPCO KIDNEY DIALYSIS TRAY |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-21 |
| Decision Date | 1983-03-29 |