FDA 510(k) Application Details - K161191

Device Classification Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable   More FDA Info for this Device
510(K) Number	K161191
Device Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant	SPIROX, INC. 3475-O EDISON WAY MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	Mike Rosenthal Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	NHB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2016
Decision Date	06/23/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review