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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K884353
Device Name ULTRX(TM) 850 ARTIFICIAL KIDNEY
Applicant
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact ANN ROADRUCK
Correspondent
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact ANN ROADRUCK
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/17/1988
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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