FDA 510(k) Application Details - K963241

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K963241
Device Name	Prosthesis, Tracheal, Expandable
Applicant	BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. NATICK, MA 01760-1537 US Other 510(k) Applications for this Company
Contact	DANIEL J DILLON 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	08/19/1996
Decision Date	11/14/1996
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