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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827123
Device Name SPECTRA (ULTRAVIOLET PRODUCTS)
Applicant
Ultralite
P.O.Box 5303
Wheatridge,  CO  80033
Correspondent
Ultralite
P.O.Box 5303
Wheatridge,  CO  80033
Date Received02/02/1982
Decision Date 03/05/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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