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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 K870689
Device Name HR-3000 REUSE ADAPTOR
Applicant
Colorado Medical, Inc.
Bergen Park Business Plz.
1202 Hwy. 74, Suite 109
Evergreen,  CO  80439
Applicant Contact JAMES T BOAG
Correspondent
Colorado Medical, Inc.
Bergen Park Business Plz.
1202 Hwy. 74, Suite 109
Evergreen,  CO  80439
Correspondent Contact JAMES T BOAG
Regulation Number876.5820
Classification Product Code
LIF  
Date Received02/19/1987
Decision Date 04/10/1987
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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