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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 K913760
Device Name PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT
Applicant
Psoralite Corp.
1401 Pineview Dr.
Columbia,  SC  29209
Applicant Contact CLYDE D CROOK
Correspondent
Psoralite Corp.
1401 Pineview Dr.
Columbia,  SC  29209
Correspondent Contact CLYDE D CROOK
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/22/1991
Decision Date 10/28/1991
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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