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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K896203
Device Name SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
Applicant
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Applicant Contact W CUNNINGHAM
Correspondent
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Correspondent Contact W CUNNINGHAM
Regulation Number880.5440
Classification Product Code
CAK  
Date Received10/26/1989
Decision Date 02/01/1990
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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