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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 K864784
Device Name SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS
Applicant
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact JARVIS, PH.D.
Correspondent
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact JARVIS, PH.D.
Regulation Number876.5820
Classification Product Code
FJK  
Date Received12/08/1986
Decision Date 01/20/1987
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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