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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hammer, Reflex, Powered
510(k) Number K904113
Device Name OPERATIVE RECORDING CAMERA
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 Number890.1450
Classification Product Code
IKO  
Date Received09/06/1990
Decision Date 10/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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