The following data is part of a premarket notification filed by American Safety Equipment Corp. with the FDA for Surgical Chisel.
| Device ID | K760959 |
| 510k Number | K760959 |
| Device Name: | SURGICAL CHISEL |
| Classification | Chisel, Osteotome, Surgical |
| Applicant | AMERICAN SAFETY EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMM |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-01 |
| Decision Date | 1976-11-15 |