The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Blade Electrode.
| Device ID | K945531 |
| 510k Number | K945531 |
| Device Name: | BLADE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-02-10 |