FDA 510(k) Application Details - K183009

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K183009
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Hemostatix Medical Technologies, LLC 8400 Wolf Lake Drive, STE 109 Bartlett, TN 38133 US Other 510(k) Applications for this Company
Contact	Jeff Cobb 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	10/31/2018
Decision Date	11/26/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review