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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 K891087
Device Name TERUMO SURFLO(R) I.V. CATHETER
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GEORGE S MOMODA
Correspondent
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GEORGE S MOMODA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/01/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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