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510(k) K925173

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT by Westmed Intl. — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
October 14, 1992
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

Other clearances by Westmed Intl.

  • K955047 — WESTMED CIRCULARIE PEP DEVICES (March 27, 1996)
  • K954271 — WESTMED CONDESATE COLLECTION TRAP (December 28, 1995)
  • K952616 — MICROTIME (September 27, 1995)
  • K953687 — WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (September 18, 1995)
  • K953506 — WESTMED RESPIRATORY LUER ADAPTOR (September 15, 1995)
  • K951484 — WESTMED BACTERIAL/VIRAL FILTER (April 24, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K924944 — INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA (July 2, 1993)

Other clearances for product code LYA

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  • K202623 — Novapak Nasal Sinus Packing and Stent (December 8, 2020)
  • 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)