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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 K925522
Device Name CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
Applicant
C.G.H. Medical, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
C.G.H. Medical, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number876.5820
Classification Product Code
KOC  
Date Received11/02/1992
Decision Date 09/30/1994
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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