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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, conductivity, non-remote
510(k) Number K853735
Device Name COLORADO MEDICAL MODEL CTM-3000
Applicant
COLORADO MEDICAL, INC.
BERGEN PARK BUSINESS PLAZA
1202 HIGHWAY 74, SUITE 109
EVERGREEN,  CO  80439
Applicant Contact SCOTT EVANS
Correspondent
COLORADO MEDICAL, INC.
BERGEN PARK BUSINESS PLAZA
1202 HIGHWAY 74, SUITE 109
EVERGREEN,  CO  80439
Correspondent Contact SCOTT EVANS
Regulation Number876.5820
Classification Product Code
FIZ  
Date Received09/06/1985
Decision Date 10/04/1985
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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