FDA 510(k) Application Details - K013648

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K013648
Device Name	Prosthesis, Tracheal, Expandable
Applicant	W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD ELKTON, MD 21922-1408 US Other 510(k) Applications for this Company
Contact	TIMOTHY J RYNN 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	11/05/2001
Decision Date	01/08/2002
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