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510(k) K111172

4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES by Daavlin Distributing Co. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2011
Date Received
April 26, 2011
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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