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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K121607
Device Name TERUMO(R) NEEDLE
Applicant
TERUMO (PHILIPPINES) CORPORATION
950 ELKTON BLVD
ELKTON,  MD  21921
Applicant Contact SANDI HARTKA
Correspondent
TERUMO (PHILIPPINES) CORPORATION
950 ELKTON BLVD
ELKTON,  MD  21921
Correspondent Contact SANDI HARTKA
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/01/2012
Decision Date 11/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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