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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K853817
Device Name COBE REN NEW-D DISPENSING KIT
Applicant
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number876.5820
Classification Product Code
LIF  
Date Received09/12/1985
Decision Date 10/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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