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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K914083
Device Name ICAN K DISSECTOR SPONGES
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 Number878.4450
Classification Product Code
GDY  
Date Received09/11/1991
Decision Date 10/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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