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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 BK150351
Tradename Typesafe 2.0 Segment Piercing Device (Model Number SP0201QD & SP0201QM)
Device Name Supplies, Blood-Bank
Original Applicant
Typenex Medical LLC
303 east wacker drive
suite 311
chicago,  IL  60601
Regulation Number864.9050
Classification Product Code
KSS  
Date Received12/04/2015
Decision Date 12/28/2015
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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