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510(k) K110858

LO-BAK TRAX by Roland F Berthiaume, DC — Product Code HST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2011
Date Received
March 28, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

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