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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K103340
Device Name SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
Applicant
Harvest Technologies, Corp.
40 Grissom Rd., Suite 100
Plymouth,  MA  02360
Applicant Contact JOHN D BONASERA
Correspondent
Harvest Technologies, Corp.
40 Grissom Rd., Suite 100
Plymouth,  MA  02360
Correspondent Contact JOHN D BONASERA
Regulation Number862.2050
Classification Product Code
JQC  
Subsequent Product Code
FMF  
Date Received11/15/2010
Decision Date 12/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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