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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K090973
Device Name TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
Applicant
TERUMO CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact LYNNE WITKOWSKI
Correspondent
TERUMO CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact LYNNE WITKOWSKI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/06/2009
Decision Date 05/01/2009
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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