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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K884243
Device Name BLOOD TUBING SET
Applicant
MEDIFLEX INTL.
45 KULICK RD.
FAIRFIELD,  NJ  07006
Applicant Contact UDINE
Correspondent
MEDIFLEX INTL.
45 KULICK RD.
FAIRFIELD,  NJ  07006
Correspondent Contact UDINE
Regulation Number876.5820
Classification Product Code
FJK  
Date Received10/11/1988
Decision Date 12/08/1988
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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