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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 K870898
Device Name ULTRA-LUX LIGHT SOURCE
Applicant
MEDLINE INDUSTRIES, INC.
99 INVERNESS DRIVE EAST
ENGLEWOOD,  CO  80112
Applicant Contact JO BREHM
Correspondent
MEDLINE INDUSTRIES, INC.
99 INVERNESS DRIVE EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JO BREHM
Regulation Number878.4580
Classification Product Code
FSW  
Date Received03/05/1987
Decision Date 03/18/1987
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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