FDA 510(k) Application Details - K233569

Device Classification Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable   More FDA Info for this Device
510(K) Number	K233569
Device Name	Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant	Spirair, Inc. 415 Grand Avenue Suite 201 San Francisco, CA 94080 US Other 510(k) Applications for this Company
Contact	Tracey Henry 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	11/06/2023
Decision Date	03/22/2024
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