The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Soft Universal Patient Return Electrode.
| Device ID | K133726 |
| 510k Number | K133726 |
| Device Name: | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Ronda Magneson |
| Correspondent | Ronda 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-06 |
| Decision Date | 2014-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559105102 | K133726 | 000 |
| 10614559104255 | K133726 | 000 |
| 10614559104248 | K133726 | 000 |
| 10614559104026 | K133726 | 000 |
| 10614559103906 | K133726 | 000 |
| 10614559104859 | K133726 | 000 |
| 10614559104842 | K133726 | 000 |