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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 K060799
Device Name COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
Applicant
COSMAN MEDICAL, INC.
76 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Applicant Contact MICHAEL ARNOLD
Correspondent
COSMAN MEDICAL, INC.
76 CAMBRIDGE ST.
BURLINGTON,  MA  01803
Correspondent Contact MICHAEL ARNOLD
Regulation Number882.4725
Classification Product Code
GXI  
Date Received03/24/2006
Decision Date 05/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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