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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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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