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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
Spectra Medical Devices, Inc.
299 Ballardvale St., Suite I,
Wilmington,  MA  01887
Correspondent Contact Kathy Dassler
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
Predetermined Change
Control Plan Authorized		 No
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