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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Cine, Surgical, Without Audio
510(k) Number K884039
Device Name MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940
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 Number878.4160
Classification Product Code
FWH  
Date Received09/26/1988
Decision Date 10/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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