510(k) K080261

IMPULSE IQ ADJUSTING INSTRUMENT by Neuromechanical Innovations, LLC — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2008
Date Received
February 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manipulator, Plunger-Like Joint
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type