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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 K182915
Device Name ENvizion Medical ENvue; 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 Road
Trout Creek,  MT  59874
Correspondent Contact Clay Anselmo
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/18/2018
Decision Date 02/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03371160
NCT03505593
Reviewed by Third Party No
Combination Product No
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