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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Microsurgical, Without Audio
510(k) Number K891236
Device Name FDX SOLID STATE VIDEO CAMERA MODEL 5950
Applicant
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Applicant Contact JO BREHM
Correspondent
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JO BREHM
Regulation Number878.4160
Classification Product Code
FWD  
Date Received03/07/1989
Decision Date 04/05/1989
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
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