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510(k) K130666

KHAN KINETIC TREATMENT (KKT-M2) by Optima Health Solutions International Corporation — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2014
Date Received
March 12, 2013
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

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