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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Accessories, Image Post-Processing For Color Enhancement
510(k) Number K150618
Device Name PENTAX Medical EPK-i7010 Video Processor with GI Family
Applicant
Pentax of America, Inc.
3 Paragon Dr.
Montvale,  NJ  07645
Applicant Contact KRISHNA GOVINDARAJAN
Correspondent
Pentax of America, Inc.
3 Paragon Dr.
Montvale,  NJ  07645
Correspondent Contact KRISHNA GOVINDARAJAN
Regulation Number876.1500
Classification Product Code
PEA  
Date Received03/10/2015
Decision Date 11/24/2015
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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