FDA 510(k) Application Details - K003100

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K003100
Device Name	Prosthesis, Tracheal, Expandable
Applicant	BOSTON SCIENTIFIC CORP. 5905 NATHAN LN. PLYMOUTH, MN 55442 US Other 510(k) Applications for this Company
Contact	RON BENNETT 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	10/03/2000
Decision Date	12/20/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review