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FDA 510(k) Application Details - K070610
Device Classification Name
Catheter, Biliary, Diagnostic
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510(K) Number
K070610
Device Name
Catheter, Biliary, Diagnostic
Applicant
ANGIOTECH
13921 PARK CENTER ROAD
SUITE 100
HERNDON, VA 20171 US
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Contact
TRUDY ESTRIDGE
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Regulation Number
876.5010
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Classification Product Code
FGE
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More FDA Info for this Product Code
Date Received
03/05/2007
Decision Date
06/21/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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