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FDA 510(k) Application Details - K963166
Device Classification Name
Ligator, Hemorrhoidal
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510(K) Number
K963166
Device Name
Ligator, Hemorrhoidal
Applicant
PATRICK J. O'REGAN
912 - 750 WEST BROADWAY
VANCOUVER V5Z 1H8 CA
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Contact
PATRICK J O'REGAN
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Regulation Number
876.4400
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Classification Product Code
FHN
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More FDA Info for this Product Code
Date Received
08/14/1996
Decision Date
05/05/1997
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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