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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K141586
Device Name OWL CANNULAE
Applicant
Diros Technology, Inc.
120 Gibson Dr.
Markham,On,  CA L3R 2Z3
Applicant Contact GEORGE DARMOS
Correspondent
Diros Technology, Inc.
120 Gibson Dr.
Markham,On,  CA L3R 2Z3
Correspondent Contact GEORGE DARMOS
Regulation Number882.4725
Classification Product Code
GXI  
Date Received06/13/2014
Decision Date 12/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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