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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 BK900034
Tradename Phlebotomist Protection Device
Device Name Supplies, Blood-Bank
Original Applicant
Haemonetics Manufacturing Inc.
400 wood road
braintree,  MA  02184
Regulation Number864.9050
Classification Product Code
KSS  
Date Received12/19/1990
Decision Date 01/27/1992
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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