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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 K083420
Device Name MEDONIC M SERIES
Applicant
BOULE MEDICAL AB
1800 N.W. 65TH AVE
PLANTATION,  FL  33313
Applicant Contact MICHAEL ELLIOTT
Correspondent
BOULE MEDICAL AB
1800 N.W. 65TH AVE
PLANTATION,  FL  33313
Correspondent Contact MICHAEL ELLIOTT
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/19/2008
Decision Date 02/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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