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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cabinet, phototherapy (puva)
510(k) Number K791116
Device Name PSORALITE SERIES 30,000
Original Applicant
PAUL B. ELDER CO.
Regulation Number878.4630
Classification Product Code
KGL  
Date Received06/15/1979
Decision Date 09/04/1979
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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