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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Dialysis, Single Needle With Uni-Directional Pump
510(k) Number K873279
Device Name 8810 PUMP-PUMP SINGLE NEEDLE DEVICE
Applicant
Cd Medical, Inc.
13520 SE Pheasant Ct.
Portland,  OR  97222
Applicant Contact ALBERT E JARVIS,PHD
Correspondent
Cd Medical, Inc.
13520 SE Pheasant Ct.
Portland,  OR  97222
Correspondent Contact ALBERT E JARVIS,PHD
Regulation Number876.5820
Classification Product Code
FIF  
Date Received08/17/1987
Decision Date 10/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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