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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, endoscopic
510(k) Number K894319
Device Name MEDICAL DYNAMICS 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
FSW  
Date Received07/14/1989
Decision Date 10/03/1989
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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