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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 K864364
Device Name WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET
Applicant
Technical Associates of New England
P.O. Box 116
Hopkinton,  MA  01748
Applicant Contact ALLAN T SCHWINN
Correspondent
Technical Associates of New England
P.O. Box 116
Hopkinton,  MA  01748
Correspondent Contact ALLAN T SCHWINN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/05/1986
Decision Date 02/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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