The following data is part of a premarket notification filed by Mega Dyne Medical Products, Inc. with the FDA for Electrosurgical Electrode.
| Device ID | K925478 |
| 510k Number | K925478 |
| Device Name: | ELECTROSURGICAL ELECTRODE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | MEGA DYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Contact | Drew D Weaver |
| Correspondent | Drew D Weaver MEGA DYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-29 |
| Decision Date | 1994-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559101227 | K925478 | 000 |
| 10614559101155 | K925478 | 000 |
| 10614559101162 | K925478 | 000 |
| 10614559101209 | K925478 | 000 |
| 10614559101216 | K925478 | 000 |
| 10614559101223 | K925478 | 000 |
| 10614559101179 | K925478 | 000 |
| 10614559101186 | K925478 | 000 |
| 10614559101193 | K925478 | 000 |
| 30614559101142 | K925478 | 000 |
| 30614559101159 | K925478 | 000 |
| 30614559101166 | K925478 | 000 |
| 30614559101173 | K925478 | 000 |
| 30614559101180 | K925478 | 000 |
| 30614559101197 | K925478 | 000 |
| 30614559101203 | K925478 | 000 |
| 30614559101210 | K925478 | 000 |
| 10614559101148 | K925478 | 000 |