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510(k) K171022

Ablation Confirmation by Neuwave Medical, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2017
Date Received
April 5, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K150313 — Ablation Confirmation (July 9, 2015)

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