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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 K955592
Device Name COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
Applicant
COBE RENAL CARE, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215 -4407
Applicant Contact JEFFREY R SHIDERMAN
Correspondent
COBE RENAL CARE, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215 -4407
Correspondent Contact JEFFREY R SHIDERMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/07/1995
Decision Date 04/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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