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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 K113422
Device Name TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
Applicant
TERUMO (PHILIPPINES) CORPORATION
#124 EAST MAIN AVE.
LAGUNA TECHNOPARK
BINAN, LAGUNA,  PH 4026
Applicant Contact SANDI HARTKA
Correspondent
TERUMO (PHILIPPINES) CORPORATION
#124 EAST MAIN AVE.
LAGUNA TECHNOPARK
BINAN, LAGUNA,  PH 4026
Correspondent Contact SANDI HARTKA
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MEG  
Date Received11/21/2011
Decision Date 03/05/2012
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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