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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K040064
Device Name NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
Applicant
Newmedical Technology, Inc.
N.14 W.23833 Stone Ridge Dr.
Suite G100, Mail Box #1
Waukesha,  WI  53188
Applicant Contact HAITHAM MATLOUB
Correspondent
Newmedical Technology, Inc.
N.14 W.23833 Stone Ridge Dr.
Suite G100, Mail Box #1
Waukesha,  WI  53188
Correspondent Contact HAITHAM MATLOUB
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/13/2004
Decision Date 03/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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