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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, esophageal
510(k) Number K132535
Device Name AUTOBAND LIGATOR
Applicant
ENDOCHOICE, INC.
11810 WILLS ROAD
ALPHARETTA,  GA  30009
Applicant Contact DANIEL HOEFER
Correspondent
ENDOCHOICE, INC.
11810 WILLS ROAD
ALPHARETTA,  GA  30009
Correspondent Contact DANIEL HOEFER
Regulation Number876.4400
Classification Product Code
MND  
Date Received08/13/2013
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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