The following data is part of a premarket notification filed by Ascep, Inc. with the FDA for Various Instruments & Instrument Trays.
| Device ID | K830219 |
| 510k Number | K830219 |
| Device Name: | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS |
| Classification | Tray, Surgical, Instrument |
| Applicant | ASCEP, INC. 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 | 1983-01-24 |
| Decision Date | 1983-04-12 |