FDA 510(k) Application Details - K984526

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K984526
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. FLAGSTAFF, AZ 86002-0500 US Other 510(k) Applications for this Company
Contact	TIMOTHY J RYNN Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	DXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/1998
Decision Date	04/08/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review