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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Ac-Powered And Accessories
510(k) Number K896008
Device Name MODEL 6500 MERCURY ARC LIGHT SOURCE
Applicant
Medical Dynamics, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Applicant Contact JO BREHM
Correspondent
Medical Dynamics, Inc.
99 Inverness Dr. E.
Englewood,  CO  80112
Correspondent Contact JO BREHM
Regulation Number876.1500
Classification Product Code
GCP  
Date Received10/13/1989
Decision Date 12/27/1989
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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