FDA 510(k) Application Details - K012746

Device Classification Name Device, Thermal, Hemorrhoids

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510(K) Number K012746
Device Name Device, Thermal, Hemorrhoids
Applicant BEHIVE LTD
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 000.0000

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Classification Product Code LKX
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Date Received 08/16/2001
Decision Date 11/14/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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