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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K851306
Device Name COBE SYSTEM 3
Applicant
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact HOLLAND HICKEY
Correspondent
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact HOLLAND HICKEY
Regulation Number876.5820
Classification Product Code
FKP  
Date Received04/01/1985
Decision Date 06/12/1985
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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