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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K021293
Device Name ARTERIA BLOOD FILTER
Applicant
Arteria Medical Science, Inc.
22 Hill St.
Newburyport,  MA  01950
Applicant Contact ALAN HINTON
Correspondent
Arteria Medical Science, Inc.
22 Hill St.
Newburyport,  MA  01950
Correspondent Contact ALAN HINTON
Regulation Number880.5440
Classification Product Code
FPB  
Subsequent Product Code
BRZ  
Date Received04/23/2002
Decision Date 08/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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