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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 K853288
Device Name FEEDING UNITS & TUBES
Applicant
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Applicant Contact AMIR PORAT
Correspondent
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Correspondent Contact AMIR PORAT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/27/1985
Decision Date 10/04/1985
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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