FDA 510(k) Application Details - K213696

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K213696
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 US Other 510(k) Applications for this Company
Contact	Sharon Sussex Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2021
Decision Date	01/21/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review