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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 K935524
Device Name PHOTOTHERAPEUTIX MODEL 3200A
Applicant
AVEX INDUSTRIES LTD.
3 DEPOT ST.
P.O. BOX 230
HUDSON FALLS,  NY  12839
Applicant Contact RAY TORRICO
Correspondent
AVEX INDUSTRIES LTD.
3 DEPOT ST.
P.O. BOX 230
HUDSON FALLS,  NY  12839
Correspondent Contact RAY TORRICO
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/16/1993
Decision Date 02/17/1995
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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