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FDA 510(k) Application Details - K033670
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K033670
Device Name
Catheter, Percutaneous
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LN.
FLAGSTAFF, AZ 86001 US
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Contact
BRANDON HANSEN
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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
11/24/2003
Decision Date
05/05/2004
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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