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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K112109
Device Name THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
Applicant
ORTHO KINEMATICS, INC.
555 13TH STREET NW
WASHINGTON,  DC  20005 -3096
Applicant Contact JOHN J SMITH
Correspondent
ORTHO KINEMATICS, INC.
555 13TH STREET NW
WASHINGTON,  DC  20005 -3096
Correspondent Contact JOHN J SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/22/2011
Decision Date 12/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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