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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K024249
Device Name TERUMO SURGUARD SAFETY SYRINGE
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact BARBARA SMITH
Correspondent
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact BARBARA SMITH
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received12/23/2002
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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