FDA 510(k) Application Details - K223167

Device Classification Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable   More FDA Info for this Device
510(K) Number	K223167
Device Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant	Spirair, Inc. 6084 Monterey Hwy, 108 San Jose, CA 95138 US Other 510(k) Applications for this Company
Contact	James Kintzing 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	10/07/2022
Decision Date	08/17/2023
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