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510(k) K210741

KLS Martin Neuro Rongeurs by KLS-Martin L.P. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2022
Date Received
March 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

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Other clearances for product code HAE

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  • K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur (October 7, 2022)
  • K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (May 4, 2021)
  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • K200383 — Wiggins Medical Surgical Instruments (July 21, 2020)
  • K180949 — Steribite (November 8, 2018)
  • K161744 — Symmetry Sharp Kerrison Rongeur (September 7, 2016)
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