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510(k) K060043

KHAN KINETIC TREATMENT DEVICE (KKT-M1) by Optima Health Solutions International, Inc. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2006
Date Received
January 6, 2006
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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