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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 K032196
Device Name NBD DISPOSABLE RF CANNULAE
Applicant
NEW BUSINESS DEVELOPMENT, LLC
605 INDUSTRIAL COURT
WOODSTOCK,  GA  30189
Applicant Contact TIMOTHY B LUSBY
Correspondent
NEW BUSINESS DEVELOPMENT, LLC
605 INDUSTRIAL COURT
WOODSTOCK,  GA  30189
Correspondent Contact TIMOTHY B LUSBY
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received07/18/2003
Decision Date 10/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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