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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K864510
Device Name PSORALITE 12800 SERIES
Applicant
Psoralite Corp.
1401 Pineview Dr.
Columbia,  SC  29209
Applicant Contact GORDON E MANN
Correspondent
Psoralite Corp.
1401 Pineview Dr.
Columbia,  SC  29209
Correspondent Contact GORDON E MANN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/14/1986
Decision Date 02/04/1987
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
Predetermined Change
Control Plan Authorized		 No
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