OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP


Device Classification Name

generator, lesion, radiofrequency

510(k) Number K021869
Device Name OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
Original Applicant
DIROS TECHNOLOGY, INC.
1837 kempton rd.
charleston, 
SC 
29412

Original Contact leslie w organ
Regulation Number 882.4400
Classification Product Code
GXD  
Subsequent Product Codes
GXI   GZL  
Date Received 06/06/2002
Decision Date 07/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No