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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 K000719
Device Name NEOCARE 20 MICRON BLOOD FILTER
Applicant
Whatman, Inc.
401 W. Morgan Rd.
Ann Arbor,  MI  48108
Applicant Contact RANDALL D BATH
Correspondent
Whatman, Inc.
401 W. Morgan Rd.
Ann Arbor,  MI  48108
Correspondent Contact RANDALL D BATH
Regulation Number880.5440
Classification Product Code
CAK  
Date Received03/03/2000
Decision Date 05/30/2000
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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