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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K904398
Device Name WATER COLUMN RELIEF VALVE
Applicant
Icn Pharmaceuticals, Inc.
Icn Plz.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Applicant Contact ALICE WEI
Correspondent
Icn Pharmaceuticals, Inc.
Icn Plz.
3300 Hyland Ave.
Costa Mesa,  CA  92626
Correspondent Contact ALICE WEI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/25/1990
Decision Date 07/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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