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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 K073503
Device Name VERSA LITE
Applicant
DIOMEDICS, INC.
24372 MCCLOUD CT.
LAGUNA NIGUEL,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
DIOMEDICS, INC.
24372 MCCLOUD CT.
LAGUNA NIGUEL,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/13/2007
Decision Date 01/23/2008
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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