FDA 510(k) Application Details - K130736

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K130736
Device Name	Instrument, Ent Manual Surgical
Applicant	HELIX MEDICAL, LLC 1110 MARK AVE. CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	THOMAS M VASSALLO Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2013
Decision Date	12/17/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review