The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Loop/square Electrode.
| Device ID | K952030 |
| 510k Number | K952030 |
| Device Name: | LOOP/SQUARE ELECTRODE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | E & M ENGINEERING, INC. P.O. BOX 11349 2116 DABNEY ROAD, SUITE A-5 Richmond, VA 23230 |
| Contact | Winny Chow |
| Correspondent | Winny Chow E & M ENGINEERING, INC. P.O. BOX 11349 2116 DABNEY ROAD, SUITE A-5 Richmond, VA 23230 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1996-07-31 |