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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 K770253
Device Name MICROFILTRATION SET MF10
Applicant
Biotest-Serum-Institut
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biotest-Serum-Institut
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
CAK  
Date Received02/09/1977
Decision Date 04/05/1977
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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