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510(k) K234155

Nimbl (model PD08-N1) by Tactile Medical — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
December 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

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