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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 K241213
Device Name PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Applicant Contact Gurvinder Singh Nanda
Correspondent
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Correspondent Contact Gurvinder Singh Nanda
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received04/30/2024
Decision Date 12/06/2024
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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