FDA 510(k) Application Details - K211019

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K211019
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Dannik LLC 941 W. Morse Blvd Suite 100 Winter Park, FL 32789 US Other 510(k) Applications for this Company
Contact	Olga Haberland 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	04/05/2021
Decision Date	10/28/2021
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