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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, transfer (blood/plasma)
510(k) Number BK970008
Tradename Terumo Sterile Tubing Welder SC-201A (TSCD)
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Terumo Medical Corporation
125 blue ball road
elkton,  MD  21921
Regulation Number864.9875
Classification Product Code
KSB  
Date Received04/15/1997
Decision Date 05/28/1998
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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