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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 K851370
Device Name INTERFACE TRANSFUSION BLOOD FILTER #35
Applicant
Medical, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Applicant Contact ADEL A MIKHAIL
Correspondent
Medical, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Correspondent Contact ADEL A MIKHAIL
Regulation Number880.5440
Classification Product Code
CAK  
Date Received04/05/1985
Decision Date 06/27/1985
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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