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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Levine
510(k) Number K914530
Device Name ICAN GT DRAINAGE BAG
Applicant
Icn Pharmaceuticals, Inc.
Icn Plz.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact STEPHEN J GOLDNER
Correspondent
Icn Pharmaceuticals, Inc.
Icn Plz.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact STEPHEN J GOLDNER
Regulation Number876.5980
Classification Product Code
FRQ  
Date Received10/11/1991
Decision Date 12/18/1991
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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