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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 K890084
Device Name PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
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 Received01/10/1989
Decision Date 05/11/1989
Decision Substantially Equivalent - With Drug (SESD)
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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