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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K113873
Device Name PENTAX EPK-I5020 VIDEO PROCESSOR
Applicant
PENTAX OF AMERICA, INC.
1129 BLOOMFIELD AVENUE
WEST CALDWELL,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
PENTAX OF AMERICA, INC.
1129 BLOOMFIELD AVENUE
WEST CALDWELL,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received12/30/2011
Decision Date 06/22/2012
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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