FDA 510(k) Application Details - K243126

Device Classification Name	Prosthesis, Tracheal, Preformed/Molded   More FDA Info for this Device
510(K) Number	K243126
Device Name	Prosthesis, Tracheal, Preformed/Molded
Applicant	Novatech SA Z.I. AthΘlia III -1058, Voie Antiope La Ciotat CEDEX 13705 FR Other 510(k) Applications for this Company
Contact	Montgomery Stuart K. 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	09/30/2024
Decision Date	10/29/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review