FDA 510(k) Application Details - K150637

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K150637
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Aerin Medical, Inc. 690 W. Fremont Avenue Unit 3 Sunnyvale, CA 94087 US Other 510(k) Applications for this Company
Contact	Scott Wolf 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	03/11/2015
Decision Date	11/19/2015
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