FDA 510(k) Application Details - K050814

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K050814
Device Name	Prosthesis, Tracheal, Expandable
Applicant	ATRIUM MEDICAL CORP. 5 WENTWORTH DR. HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	JOSEPH P PAOLO Other 510(k) Applications for this Contact
Regulation Number	878.3720   More FDA Info for this Regulation Number
Classification Product Code	JCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2005
Decision Date	05/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review