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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 K881385
Device Name PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL
Applicant
PSORALITE CORP.
1401 PINEVIEW DR.
COLUMBIA,  SC  29209
Applicant Contact CLYDE CROOK
Correspondent
PSORALITE CORP.
1401 PINEVIEW DR.
COLUMBIA,  SC  29209
Correspondent Contact CLYDE CROOK
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/04/1988
Decision Date 04/13/1988
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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