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510(k) K202623

Novapak Nasal Sinus Packing and Stent by Medtronic Xomed — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2020
Date Received
September 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type

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Other clearances for product code LYA

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  • K181696 — ChitoZolve (November 30, 2018)
  • K180141 — SPIWay Endonasal Access Guide (February 16, 2018)
  • K170913 — Composite Removable Sinus Stent System (December 15, 2017)
  • K172179 — Chitogel Endoscopic Sinus Surgery Kit (October 17, 2017)
  • K153686 — SPIWay Endonasal Access Guide (January 28, 2016)
  • K141816 — HEMOPORE (October 23, 2014)
  • K141704 — NOVASHIELD INJECTABLE NASAL PACKING AND STENT (October 6, 2014)