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510(k) K073066

308 DERMATOLOGICAL EXCIMER SYSTEM by Quantel Medical, Inc. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2007
Date Received
October 30, 2007
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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