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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 BK980008
Tradename Bloodpack Needle Protector (BNP)
Device Name Supplies, Blood-Bank
Original Applicant
ITL Corporation, LTD.
22 molonglo mall
fyshwick,  Canberra,  2609, 
Regulation Number864.9050
Classification Product Code
KSS  
Date Received03/23/1998
Decision Date 04/07/1998
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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