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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K191844
Device Name Fidmi Low Profile Enteral Feeding Device
Applicant
Fidmi Medical, Ltd.
5 Haeshel St.
Caesarea Business Park, Caesarea,  IL 3079500
Applicant Contact Shahar Millis
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number876.5980
Classification Product Code
KGC  
Subsequent Product Code
KNT  
Date Received07/09/2019
Decision Date 09/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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