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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 K102778
Device Name CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
Applicant
CELLAVISION AB
435 RICE CREEK TERRACE NE
FRIDLEY,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
CELLAVISION AB
435 RICE CREEK TERRACE NE
FRIDLEY,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number864.5260
Classification Product Code
JOY  
Date Received09/24/2010
Decision Date 09/16/2011
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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