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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 K172677
Device Name Advantage Plus Pass-Thru
Applicant
Medivators Inc.
14605 28th Avenue North
Minneapolis,  MN  55447
Applicant Contact Megan Skaar
Correspondent
Medivators Inc.
14605 28th Avenue North
Minneapolis,  MN  55447
Correspondent Contact Megan Skaar
Regulation Number876.1500
Classification Product Code
FEB  
Date Received09/05/2017
Decision Date 12/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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