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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 K152362
Device Name Terumo SurGuard 3 Safety Hypodermic Needle
Applicant
TERUMO (PHILIPPINES) CORPORATION
124 EAST MAIN AVENUE, LAGUNA TECHNOPARK
BINAN,  PH
Applicant Contact PHEBE VARGHESE
Correspondent
TERUMO MEDICAL CORPORATION
265 DAVIDSON AVENUE, SUITE 320
SOMERSET,  NJ  08873
Correspondent Contact PHEBE VARGHESE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/20/2015
Decision Date 10/16/2015
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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