The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Electrosurgical Unit.
| Device ID | K921271 |
| 510k Number | K921271 |
| Device Name: | ELECTROSURGICAL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | E & M ENGINEERING, INC. P.O. BOX 11349 2116 DABNEY ROAD, SUITE A-5 Richmond, VA 23230 |
| Contact | Duncan Fung |
| Correspondent | Duncan Fung E & M ENGINEERING, INC. P.O. BOX 11349 2116 DABNEY ROAD, SUITE A-5 Richmond, VA 23230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1993-07-02 |