FDA 510(k) Application Details - K991602

Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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510(K) Number K991602
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant W.L. GORE & ASSOCIATES,INC
3450 WEST KILTIE LN.
FLAGSTAFF,, AZ 86002 US
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Contact TIMOTHY J RYAN
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 05/10/1999
Decision Date 07/09/1999
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



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