The following data is part of a premarket notification filed by Ascep, Inc. with the FDA for G.e.v. Disposable Scalpels.
| Device ID | K822893 |
| 510k Number | K822893 |
| Device Name: | G.E.V. DISPOSABLE SCALPELS |
| Classification | Scalpel, One-piece |
| Applicant | ASCEP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-28 |
| Decision Date | 1982-10-22 |