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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 K072787
Device Name GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
Applicant
Syncro Medical Innovations, Inc.
342 E. Main St.
Suite 207
Leola,  PA  17540
Applicant Contact WILLIAM MCLAIN
Correspondent
Syncro Medical Innovations, Inc.
342 E. Main St.
Suite 207
Leola,  PA  17540
Correspondent Contact WILLIAM MCLAIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/01/2007
Decision Date 10/31/2007
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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