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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 K880506
Device Name MODIFIED EVA-MIX AND DI-MIX BAGS
Applicant
Gil-Med Industries C/O Kegan & Kegan, Ltd.
79 W. Monroe St., Suite 1320
Chicago,  IL  60603
Applicant Contact ESTER O KEGAN
Correspondent
Gil-Med Industries C/O Kegan & Kegan, Ltd.
79 W. Monroe St., Suite 1320
Chicago,  IL  60603
Correspondent Contact ESTER O KEGAN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received02/08/1988
Decision Date 05/20/1988
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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