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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Container, I.V.
510(k) Number K841597
Device Name GIL-MED PARENTERAL NUTRITION OR MEDICINE
Applicant
Gil-Med Industries C/O Kegan & Kegan, Ltd.
79 W. Monroe St., Suite 1320
Chicago,  IL  60603
Applicant Contact O KEGAN
Correspondent
Gil-Med Industries C/O Kegan & Kegan, Ltd.
79 W. Monroe St., Suite 1320
Chicago,  IL  60603
Correspondent Contact O KEGAN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received04/18/1984
Decision Date 10/26/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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