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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 K080261
Device Name IMPULSE IQ ADJUSTING INSTRUMENT
Applicant
Neuromechanical Innovations, LLC
11011 S. 48th St., Suite 220
Phoenix,  AZ  85044
Applicant Contact CHRISTOPHER J COLLOCA
Correspondent
Neuromechanical Innovations, LLC
11011 S. 48th St., Suite 220
Phoenix,  AZ  85044
Correspondent Contact CHRISTOPHER J COLLOCA
Classification Product Code
LXM  
Date Received02/01/2008
Decision Date 04/11/2008
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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