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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K191387
Device Name ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
Applicant
Envizion Medical , Ltd.
7 Haarad St.
Tel Aviv,  IL 6971060
Applicant Contact Doron Besser
Correspondent
Shriner & Associates
429 Whitepine Creek Rd.
Trout Creek,  MT  59872
Correspondent Contact Clay Anselmo
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/24/2019
Decision Date 06/14/2019
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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