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510(k) K130399

CERTUS 140 CERTUSURGGT SURGICAL TOOL by Neuwave Medical, Inc. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2013
Date Received
February 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K163118 — FLEX Microwave Ablation System and Accessories (March 9, 2017)
  • K161285 — Ablation Confirmation (June 29, 2016)
  • K160936 — Certus 140 2.45GHz Ablation System (May 4, 2016)

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