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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 K122249
Device Name TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
Applicant
Terumo (Philippines) Corporation
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact PHILLIP LESTER
Correspondent
Terumo (Philippines) Corporation
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact PHILLIP LESTER
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MEG  
Date Received07/27/2012
Decision Date 08/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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