The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Custom Universal Cutdown Prep Tray.
| Device ID | K801965 |
| 510k Number | K801965 |
| Device Name: | CUSTOM UNIVERSAL CUTDOWN PREP TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-10-10 |