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510(k) K050695

FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT by Daavlin Distributing Co. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2005
Date Received
March 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

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