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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K041882
Device Name FLOWCARE SYSTEM
Applicant
Pointcare Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Pointcare Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/12/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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