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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Hematocrit Measuring
510(k) Number K850391
Device Name PLASMA EXTRACTION SYSTEM
Applicant
HANS J. BROUWERS & ASSOC.
P.O. BOX 823
MOUNT PROSPECT,  IL  60056
Applicant Contact HANS J BROUWERS
Correspondent
HANS J. BROUWERS & ASSOC.
P.O. BOX 823
MOUNT PROSPECT,  IL  60056
Correspondent Contact HANS J BROUWERS
Regulation Number864.6400
Classification Product Code
JPI  
Date Received02/01/1985
Decision Date 05/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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