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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 K080771
Device Name TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
Applicant
TOP CORP.
5536 TROWBRIDGE DR
DUNWOODY,  GA  30338
Applicant Contact CATHRYN N CAMBRIA
Correspondent
TOP CORP.
5536 TROWBRIDGE DR
DUNWOODY,  GA  30338
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number882.4725
Classification Product Code
GXI  
Date Received03/19/2008
Decision Date 11/10/2008
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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