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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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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