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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 K823261
Device Name INTERFACE TRANSFUSION BLOOD FILTER #30
Applicant
Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
CAK  
Date Received11/02/1982
Decision Date 01/07/1983
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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