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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K050377
Device Name NBD HEAD SCREW
Applicant
New Business Development, LLC
605 Industrial Ct.
Woodstock,  GA  30189
Applicant Contact TIM B LUSBY
Correspondent
New Business Development, LLC
605 Industrial Ct.
Woodstock,  GA  30189
Correspondent Contact TIM B LUSBY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/15/2005
Decision Date 04/07/2005
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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