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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K201741
Device Name Gabriel 3 Way EnFit Valve
Applicant
Syncro Medical Innovations, Inc.
515 Mulberry St.
Macon,  GA  31201
Applicant Contact Sabry Gabriel
Correspondent
Syncro Medical Innovations, Inc.
515 Mulberry St.
Macon,  GA  31201
Correspondent Contact Sabry Gabriel
Regulation Number876.5980
Classification Product Code
PIF  
Date Received06/25/2020
Decision Date 11/05/2020
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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