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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 K160787
Device Name Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
Applicant
Syncro Medical Innovations, Inc.
515 Mulberry St., Suite 200
Macon,  GA  31201
Applicant Contact Sabry Gabriel
Correspondent
Keystone Regulatory Services, LLC
342 E. Main St.
Suite 207
Leola,  PA  17540
Correspondent Contact Bill Mclain
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/22/2016
Decision Date 08/09/2016
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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