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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K140753
Device Name ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
Applicant
Medivators
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact KINNARI SHAH
Correspondent
Medivators
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact KINNARI SHAH
Regulation Number876.1500
Classification Product Code
OCX  
Date Received03/26/2014
Decision Date 07/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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