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510(k) K093185

OWL UNIVERSAL RF SYSTEM URF-3AP (ML) by Diros Technology, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2010
Date Received
October 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

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  • K021869 — OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP (July 1, 2002)

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