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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 K050084
Device Name COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
Applicant
COSMAN MEDICAL, INC.
76 CAMBRIDGE ST.
BURLINGTON,  MA  01803 -4140
Applicant Contact MICHAEL ARNOLD
Correspondent
COSMAN MEDICAL, INC.
76 CAMBRIDGE ST.
BURLINGTON,  MA  01803 -4140
Correspondent Contact MICHAEL ARNOLD
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received01/13/2005
Decision Date 03/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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