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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K941803
Device Name PRISM MEDICAL CUSTOM DIALYSIS KIT
Applicant
Medical Device Support Services
4840 Portsmouth Blvd.
El Paso,  TX  79922
Applicant Contact WALTER MCQUADE
Correspondent
Medical Device Support Services
4840 Portsmouth Blvd.
El Paso,  TX  79922
Correspondent Contact WALTER MCQUADE
Regulation Number876.5820
Classification Product Code
KOC  
Date Received04/12/1994
Decision Date 01/30/1995
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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