510(k) K021869

OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP by Diros Technology, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2002
Date Received
June 6, 2002
Clearance Type
Special
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