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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 K810761
Device Name ALPHA MICRON-40 FILTER
Applicant
ALPHA THERAPEUTIC CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ALPHA THERAPEUTIC CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
CAK  
Date Received03/20/1981
Decision Date 06/30/1981
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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