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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 K110005
Device Name SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
Applicant
SYNCRO MEDICAL INNOVATIONS, INC.
342 E MAIN STREET, SUITE 207
LEOLA,  PA  17540
Applicant Contact WILLIAM G MCLAIN
Correspondent
SYNCRO MEDICAL INNOVATIONS, INC.
342 E MAIN STREET, SUITE 207
LEOLA,  PA  17540
Correspondent Contact WILLIAM G MCLAIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/03/2011
Decision Date 08/04/2011
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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