OWL RF PROBES


Device Classification Name

probe, radiofrequency lesion

510(k) Number K110593
Device Name OWL RF PROBES
Applicant
DIROS TECHNOLOGY, INC.
232 hood road
markham, ontario, 

CA

l3r 3k8

Applicant Contact george darmos
Correspondent
DIROS TECHNOLOGY, INC.
232 hood road
markham, ontario, 

CA

l3r 3k8

Correspodent Contact george darmos
Regulation Number 882.4725
Classification Product Code
GXI  
Date Received 03/02/2011
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No