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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 K052660
Device Name MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO
Applicant
The Richmond Light Co.
2301 Falkirk Dr.
Richmond,  VA  23236
Applicant Contact ALEX M CLARKE
Correspondent
The Richmond Light Co.
2301 Falkirk Dr.
Richmond,  VA  23236
Correspondent Contact ALEX M CLARKE
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/27/2005
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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