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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K983490
Device Name TERUMO VENOJECT,LUER ADAPTER
Applicant
Terumo Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact KRISTINE WAGNER
Correspondent
Terumo Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact KRISTINE WAGNER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received10/05/1998
Decision Date 11/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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