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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 BK950058
Tradename Terumo Sampling Site Coupler
Device Name Supplies, Blood-Bank
Original Applicant
Terumo Corporation
2100 cottontail lane
somerset,  NJ  08873
Regulation Number864.9050
Classification Product Code
KSS  
Date Received10/17/1995
Decision Date 11/13/1995
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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