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510(k) K050428

TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) by Advanced Spinal Technologies, Inc. — Product Code LXM

K050428 is an FDA 510(k) premarket notification submitted by Advanced Spinal Technologies, Inc. for the device "TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)". The FDA issued a decision of Substantially Equivalent on June 14, 2005. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2005
Date Received
February 18, 2005
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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FDA data resources