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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 K930856
Device Name PSORALITE
Applicant
DAAVLIN CO.
P.O. BOX 626
205 W. BEMENT STREET
BRYAN,  OH  43506
Applicant Contact DAVID W SWANSON
Correspondent
DAAVLIN CO.
P.O. BOX 626
205 W. BEMENT STREET
BRYAN,  OH  43506
Correspondent Contact DAVID W SWANSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/18/1993
Decision Date 08/26/1993
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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