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FDA 510(k) Application Details - K974018
Device Classification Name
Ligator, Hemorrhoidal
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510(K) Number
K974018
Device Name
Ligator, Hemorrhoidal
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM, NC 27105 US
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Contact
PAULA JOYCE
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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
10/22/1997
Decision Date
01/20/1998
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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