The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Reusable, Hand Controlled Esp.
| Device ID | K936075 |
| 510k Number | K936075 |
| Device Name: | REUSABLE, HAND CONTROLLED ESP |
| 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 | 1993-12-20 |
| Decision Date | 1994-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50653405041090 | K936075 | 000 |
| 20653405041099 | K936075 | 000 |