FDA 510(k) Application Details - K191073

Device Classification Name	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed   More FDA Info for this Device
510(K) Number	K191073
Device Name	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant	Vein360, LLC 4460 Lake Forest Drive Blue Ash, OH 45242-3741 US Other 510(k) Applications for this Company
Contact	Suzanne Meyer Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2019
Decision Date	10/22/2019
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