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510(k) K192629

Spinalytics by Optima Health Solutions International Corp. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2019
Date Received
September 23, 2019
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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  • K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1) (March 23, 2006)
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