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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K023462
Device Name IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003
Applicant
NEUROMECHANICAL INNOVATIONS, LLC
11011 S. 48TH ST.
SUITE 205
PHOENIX,  AZ  85044
Applicant Contact CHRISTOPHER J COLLOCA
Correspondent
NEUROMECHANICAL INNOVATIONS, LLC
11011 S. 48TH ST.
SUITE 205
PHOENIX,  AZ  85044
Correspondent Contact CHRISTOPHER J COLLOCA
Classification Product Code
LXM  
Date Received10/15/2002
Decision Date 01/13/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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