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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 K082863
Device Name DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
Applicant
Dynarex Corporation
10 Glenshaw St.
Orangeburg,  NY  10962
Applicant Contact JAMES HURLMAN
Correspondent
Dynarex Corporation
10 Glenshaw St.
Orangeburg,  NY  10962
Correspondent Contact JAMES HURLMAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/29/2008
Decision Date 01/09/2009
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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