FDA 510(k) Application Details - K131282

Device Classification Name Ligator, Hemorrhoidal

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510(K) Number K131282
Device Name Ligator, Hemorrhoidal
Applicant INX MEDICAL
1819 CLARKSON ROAD
SUITE 206
CHESTERFIELD, MO 63017 US
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Contact PAUL DRYDEN
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Regulation Number 876.4400

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Classification Product Code FHN
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Date Received 05/06/2013
Decision Date 07/11/2013
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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