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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Non Heating
510(k) Number K910091
FOIA Releasable 510(k) K910091
Device Name ULTRALITE PANELITE
Applicant
Ultralite
390 Farmer Ct.
Lawrenceville,  GA  30245
Applicant Contact WILLIAM C MCMILLAN
Correspondent
Ultralite
390 Farmer Ct.
Lawrenceville,  GA  30245
Correspondent Contact WILLIAM C MCMILLAN
Regulation Number890.5500
Classification Product Code
IOB  
Date Received01/09/1991
Decision Date 05/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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