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FDA 510(k) Application Details - K010450
Device Classification Name
Balloon, Liver Tamponade
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510(K) Number
K010450
Device Name
Balloon, Liver Tamponade
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact
LISA HOPKINS
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Regulation Number
876.5980
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Classification Product Code
NGU
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More FDA Info for this Product Code
Date Received
02/15/2001
Decision Date
09/06/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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