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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 K870028
Device Name SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
Applicant
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
Applicant Contact COSMAN, PHD
Correspondent
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
Correspondent Contact COSMAN, PHD
Regulation Number882.4725
Classification Product Code
GXI  
Date Received01/05/1987
Decision Date 10/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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