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FDA 510(k) Application Details - K963849
Device Classification Name
Bag, Bile Collecting
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510(K) Number
K963849
Device Name
Bag, Bile Collecting
Applicant
MANAN MEDICAL PRODUCTS, INC.
2200 CARLSON DR.
NORTHBROOK, IL 60062 US
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Contact
MICHAEL PLISHKA
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Regulation Number
876.5010
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Classification Product Code
EXF
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More FDA Info for this Product Code
Date Received
09/25/1996
Decision Date
12/13/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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