FDA 510(k) Application Details - K131745

Device Classification Name	Button, Nasal Septal   More FDA Info for this Device
510(K) Number	K131745
Device Name	Button, Nasal Septal
Applicant	HELIX MEDICAL, LLC 1110 MARK AVE. CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2013
Decision Date	09/17/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review