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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 K031453
Device Name TERUMO SURGUARD 2 SAFETY NEEDLE
Applicant
Terumo Medical Corp.
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact BARBARA SMITH
Correspondent
Terumo Medical Corp.
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact BARBARA SMITH
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MEG  
Date Received05/07/2003
Decision Date 07/08/2003
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
Predetermined Change
Control Plan Authorized		 No
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