FDA 510(k) Application Details - K213969

Device Classification Name	Prosthesis, Tracheal, Preformed/Molded   More FDA Info for this Device
510(K) Number	K213969
Device Name	Prosthesis, Tracheal, Preformed/Molded
Applicant	New COS Inc. DBA VisionAir Solutions 7100 Euclid Ave, Ste 180 Cleveland, OH 44103 US Other 510(k) Applications for this Company
Contact	Keith Grafmeyer Other 510(k) Applications for this Contact
Regulation Number	878.3720   More FDA Info for this Regulation Number
Classification Product Code	NWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2021
Decision Date	10/07/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review