The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Power Electrosurgical Generator.
| Device ID | K050579 |
| 510k Number | K050579 |
| Device Name: | MEGA POWER ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Ronda K Magneson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-07 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614559101933 | K050579 | 000 |
| 10614559103111 | K050579 | 000 |
| 10614559103128 | K050579 | 000 |
| 10614559103135 | K050579 | 000 |
| 10614559103340 | K050579 | 000 |
| 10614559103371 | K050579 | 000 |
| 10614559103715 | K050579 | 000 |
| 10614559103746 | K050579 | 000 |
| 10614559103753 | K050579 | 000 |
| 10614559103081 | K050579 | 000 |
| 10614559103074 | K050579 | 000 |
| 10614559103067 | K050579 | 000 |
| 10614559101940 | K050579 | 000 |
| 10614559101957 | K050579 | 000 |
| 10614559102893 | K050579 | 000 |
| 10614559103012 | K050579 | 000 |
| 10614559103029 | K050579 | 000 |
| 10614559103036 | K050579 | 000 |
| 10614559103043 | K050579 | 000 |
| 10614559103050 | K050579 | 000 |
| 10614559103760 | K050579 | 000 |
| 10614559103777 | K050579 | 000 |
| 10614559103937 | K050579 | 000 |
| 10614559105283 | K050579 | 000 |
| 10614559105290 | K050579 | 000 |
| 10614559105306 | K050579 | 000 |
| 10614559105313 | K050579 | 000 |
| 10614559103968 | K050579 | 000 |
| 10614559104170 | K050579 | 000 |
| 10614559104507 | K050579 | 000 |
| 10614559102879 | K050579 | 000 |
| 10614559105276 | K050579 | 000 |
| 10614559105269 | K050579 | 000 |
| 10614559104682 | K050579 | 000 |
| 10614559103975 | K050579 | 000 |
| 10614559103982 | K050579 | 000 |
| 10614559104279 | K050579 | 000 |
| 10614559104286 | K050579 | 000 |
| 10614559104293 | K050579 | 000 |
| 10614559104309 | K050579 | 000 |
| 10614559104316 | K050579 | 000 |
| 10614559104415 | K050579 | 000 |
| 10614559102886 | K050579 | 000 |