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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Storage Cover
510(k) Number K191011
Device Name Scope ProTech
Applicant
Meditech Endoscopy, Ltd.
Bowden House, Luckyn Ln.
Basildon,  GB ss14 3ax
Applicant Contact Peter Ramsey
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number876.1500
Classification Product Code
OCU  
Date Received04/16/2019
Decision Date 05/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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