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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 K231249
Device Name PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
Applicant
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Applicant Contact William Goeller
Correspondent
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Correspondent Contact William Goeller
Regulation Number876.1500
Classification Product Code
PEA  
Subsequent Product Codes
FDF   FDS  
Date Received05/01/2023
Decision Date 07/28/2023
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
Recalls CDRH Recalls
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