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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K914081
Device Name ICAN COTTON RAYON BALLS
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 Number880.5300
Classification Product Code
FRL  
Date Received09/11/1991
Decision Date 10/09/1991
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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