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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
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