The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Electrosurgical Cutting And Coagulating Device And Accessories.
| Device ID | K943055 |
| 510k Number | K943055 |
| Device Name: | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Drew D Weaver |
| Correspondent | Drew D Weaver MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1994-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559101869 | K943055 | 000 |
| 10614559101261 | K943055 | 000 |
| 10614559101254 | K943055 | 000 |
| 10614559101247 | K943055 | 000 |
| 10614559101230 | K943055 | 000 |
| 10614559101117 | K943055 | 000 |
| 10614559101100 | K943055 | 000 |
| 10614559101094 | K943055 | 000 |
| 10614559101087 | K943055 | 000 |
| 10614559101070 | K943055 | 000 |
| 10614559101063 | K943055 | 000 |
| 10614559101865 | K943055 | 000 |
| 30614559101050 | K943055 | 000 |
| 30614559101067 | K943055 | 000 |
| 30614559101852 | K943055 | 000 |
| 30614559101265 | K943055 | 000 |
| 30614559101258 | K943055 | 000 |
| 30614559101241 | K943055 | 000 |
| 30614559101234 | K943055 | 000 |
| 30614559101111 | K943055 | 000 |
| 30614559101104 | K943055 | 000 |
| 30614559101098 | K943055 | 000 |
| 30614559101081 | K943055 | 000 |
| 30614559101074 | K943055 | 000 |
| 10614559101056 | K943055 | 000 |