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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K131991
FOIA Releasable 510(k) K131991
Device Name ENDOCHOICE HOT BIOPSY FORCEPS
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 Number876.4300
Classification Product Code
KGE  
Date Received06/28/2013
Decision Date 10/15/2013
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
Predetermined Change
Control Plan Authorized		 No
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