The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for I.m. Scalpel Handle.
| Device ID | K810720 |
| 510k Number | K810720 |
| Device Name: | I.M. SCALPEL HANDLE |
| Classification | Handle, Scalpel |
| Applicant | INSTRUMENT MAKAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-17 |
| Decision Date | 1981-04-03 |