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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, processing for frozen blood
510(k) Number BK030031
Tradename Haemonetics Model 215 Automated Glycerolyzation / Deglycerolyzationand Cell Washing System
Device Name System, Processing for Frozen Blood
Original Applicant
Haemonetics Corporation
400 wood road
braintree,  MA  02184 9114
Regulation Number864.9145
Classification Product Code
KSW  
Date Received05/14/2003
Decision Date 09/10/2003
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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