FDA 510(k) Application Details - K964121

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K964121
Device Name	Prosthesis, Tracheal, Expandable
Applicant	BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. MINNEAPOLIS, MN 55442 US Other 510(k) Applications for this Company
Contact	CATHY YOHNK 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	10/15/1996
Decision Date	12/04/1996
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