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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K904609
Device Name XENON LIGHT SOURCE
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 Number878.4580
Classification Product Code
HBI  
Date Received10/11/1990
Decision Date 12/18/1990
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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