The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch.
Device ID | K193145 |
510k Number | K193145 |
Device Name: | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 |
Contact | Sharon Sussex |
Correspondent | Kweku Biney Ethicon Endo-Surgery LLC 4545 Creek Road Cincinnati, OH 45242 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-13 |
Decision Date | 2020-03-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10614559105597 | K193145 | 000 |
10614559105634 | K193145 | 000 |