FDA 510(k) Application Details - K971509

Device Classification Name	Prosthesis, Tracheal, Preformed/Molded   More FDA Info for this Device
510(K) Number	K971509
Device Name	Prosthesis, Tracheal, Preformed/Molded
Applicant	Novatech S.A. AVENUE DU VENT DES DAMES ZI LES PALUDS AUBAGNE 13685 FR Other 510(k) Applications for this Company
Contact	BRUNO FERREYROL 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	04/25/1997
Decision Date	08/21/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review