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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
Predetermined Change
Control Plan Authorized		 No
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