The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Soft Reusable Patient Return Electrode.
| Device ID | K080741 |
| 510k Number | K080741 |
| Device Name: | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Ronda K Magneson |
| Correspondent | Ronda K Magneson 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 | 2008-03-17 |
| Decision Date | 2008-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614559103395 | K080741 | 000 |
| 10614559105184 | K080741 | 000 |
| 10614559105191 | K080741 | 000 |
| 10614559105207 | K080741 | 000 |
| 10614559105214 | K080741 | 000 |
| 10614559105221 | K080741 | 000 |
| 10614559105238 | K080741 | 000 |
| 10614559105245 | K080741 | 000 |
| 10614559105252 | K080741 | 000 |
| 10614559103159 | K080741 | 000 |
| 10614559105177 | K080741 | 000 |