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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, cleaning, for endoscope
510(k) Number K213833
Device Name SCOPE BUDDY PLUS Endoscope Flushing Aid
Applicant
Medivators Inc
14605 28th Ave North
Minneapolis,  MN  55447
Applicant Contact Mark Arnold
Correspondent
Medivators Inc
14605 28th Ave North
Minneapolis,  MN  55447
Correspondent Contact Mark Arnold
Regulation Number876.1500
Classification Product Code
FEB  
Date Received12/09/2021
Decision Date 01/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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