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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K132776
Device Name SEAL BIOPSY VALVE - REUSABLE
Applicant
Endochoice, Inc.
11810 Wills Rd.
Alpharetta,  GA  30009
Applicant Contact DANIEL HOEFER
Correspondent
Endochoice, Inc.
11810 Wills Rd.
Alpharetta,  GA  30009
Correspondent Contact DANIEL HOEFER
Regulation Number876.1500
Classification Product Code
OCX  
Date Received09/05/2013
Decision Date 12/20/2013
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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