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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 K780145
Device Name BLOOD FILTER, MICROEMBOLI-ATS-F10
Applicant
Sorensen Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sorensen Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
CAK  
Date Received01/30/1978
Decision Date 02/02/1978
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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