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FDA 510(k) Application Details - K081799
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K081799
Device Name
Catheter, Percutaneous
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LANE
FLAGSTAFF, AZ 86001 US
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Contact
KANU H VADODARIA
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
06/25/2008
Decision Date
10/03/2008
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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