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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K092116
Device Name EASYCELL CELL LOCATOR
Applicant
MEDICA CORP.
163 CABOT STREET
BEVERLY,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
MEDICA CORP.
163 CABOT STREET
BEVERLY,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number864.5260
Classification Product Code
JOY  
Date Received07/14/2009
Decision Date 05/12/2010
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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