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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK000037
Tradename Harvest PRP Separation System
Device Name Supplies, Blood-Bank
Original Applicant
Harvest Technologies Corp
40 grissom road
plymouth,  MA  02360
Regulation Number864.9050
Classification Product Code
KSS  
Date Received08/11/2000
Decision Date 02/05/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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