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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K900643
Device Name FLUID SOAKERSHIELD
Applicant
Infection Control Products, Inc.
P.O. Drawer 739
1019 Grubbs Ave.
Gardendale,  AL  35071
Applicant Contact JOHN P RUSSELL
Correspondent
Infection Control Products, Inc.
P.O. Drawer 739
1019 Grubbs Ave.
Gardendale,  AL  35071
Correspondent Contact JOHN P RUSSELL
Regulation Number880.6060
Classification Product Code
KME  
Date Received02/09/1990
Decision Date 04/25/1990
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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