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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastroscope and accessories, flexible/rigid
510(k) Number K131422
Device Name PEERSCOPE SYSTEM
Applicant
ENDOCHOICE, INC.
2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH)
POB 3161
CAESAREA,  IL 38900
Applicant Contact TAMAR FUERST
Correspondent
ENDOCHOICE, INC.
2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH)
POB 3161
CAESAREA,  IL 38900
Correspondent Contact TAMAR FUERST
Regulation Number876.1500
Classification Product Code
FDS  
Date Received05/16/2013
Decision Date 10/10/2013
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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