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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K891062
Device Name TERUMO AV FISTULA NEEDLE SET
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 Number876.5540
Classification Product Code
FIE  
Date Received03/01/1989
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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