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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 K131183
Device Name MED-RX ORAL/ENTERAL SYRINGE
Applicant
BENLAN, INC.
2760 BRIGHTON RD.
OAKVILLE, ONTARIO,  CA L6H 5T4
Applicant Contact CHERYL BROWN
Correspondent
BENLAN, INC.
2760 BRIGHTON RD.
OAKVILLE, ONTARIO,  CA L6H 5T4
Correspondent Contact CHERYL BROWN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/26/2013
Decision Date 06/03/2014
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
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