The following data is part of a premarket notification filed by Ascep, Inc. with the FDA for Suture Removal Tray, Reorder 7950&7951.
| Device ID | K791889 |
| 510k Number | K791889 |
| Device Name: | SUTURE REMOVAL TRAY, REORDER 7950&7951 |
| 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 | 1979-09-11 |
| Decision Date | 1979-10-17 |