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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 K110593
Device Name OWL RF PROBES
Applicant
Diros Technology, Inc.
232 Hood Rd.
Markham, Ontario,  CA L3R 3K8
Applicant Contact GEORGE DARMOS
Correspondent
Diros Technology, Inc.
232 Hood Rd.
Markham, Ontario,  CA L3R 3K8
Correspondent Contact GEORGE DARMOS
Regulation Number882.4725
Classification Product Code
GXI  
Date Received03/02/2011
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
Predetermined Change
Control Plan Authorized		 No
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