The following data is part of a premarket notification filed by Surgical Products Corp. with the FDA for Mach I Electrosurgery Hand Control.
| Device ID | K834434 |
| 510k Number | K834434 |
| Device Name: | MACH I ELECTROSURGERY HAND CONTROL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGICAL PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-04-25 |