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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, hemorrhoidal
510(k) Number K131282
Device Name NEXUS HEMORRHOID LIGATOR
Applicant
INX MEDICAL
1819 CLARKSON ROAD
SUITE 206
CHESTERFIELD,  MO  63017
Applicant Contact PAUL DRYDEN
Correspondent
INX MEDICAL
1819 CLARKSON ROAD
SUITE 206
CHESTERFIELD,  MO  63017
Correspondent Contact PAUL DRYDEN
Regulation Number876.4400
Classification Product Code
FHN  
Date Received05/06/2013
Decision Date 07/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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