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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K063729
Device Name DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
Applicant
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Applicant Contact MAURICE ROOST
Correspondent
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Correspondent Contact MAURICE ROOST
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received12/15/2006
Decision Date 08/21/2007
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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