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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 K862489
Device Name ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
Applicant
Knight Medical, Inc.
335 Newbury St.
Boston,  MA  02115
Applicant Contact STEPHEN SUTTON
Correspondent
Knight Medical, Inc.
335 Newbury St.
Boston,  MA  02115
Correspondent Contact STEPHEN SUTTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/30/1986
Decision Date 09/23/1986
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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