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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System Accessories, Extracorporeal
510(k) Number K863471
Device Name COLORADO MEDICAL MODEL PTC 1000
Applicant
Colorado Medical, Inc.
Bergen Park Business Plz.
1202 Hwy. 74, Suite 109
Evergreen,  CO  80439
Applicant Contact THOMAS E JONES
Correspondent
Colorado Medical, Inc.
Bergen Park Business Plz.
1202 Hwy. 74, Suite 109
Evergreen,  CO  80439
Correspondent Contact THOMAS E JONES
Regulation Number876.5820
Classification Product Code
KXM  
Date Received09/09/1986
Decision Date 10/02/1986
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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