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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 K062946
Device Name TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
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 Received09/28/2006
Decision Date 02/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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