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510(k) K942025

BURGET NASAL STENT by Bivona Medical Technologies — Product Code LWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
April 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Nasal
Device Class
Class I
Regulation Number
874.3900
Review Panel
EN
Submission Type

Other clearances by Bivona Medical Technologies

  • K952700 — SUPERSLICK (October 31, 1995)
  • K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (October 27, 1994)
  • K935053 — BIVONA NASAL TURBINATE STENT (July 1, 1994)
  • K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE (October 6, 1993)
  • K931749 — BIVONA(R) ICU ENDOTRACHEAL TUBE (August 10, 1993)
  • K922665 — BIVONA HYPERFLEX TRACHEOSTOMY TUBE (January 7, 1993)
  • K923878 — BIVONA CUSTOMIZED TRACHEOSTOMY TUBES (December 29, 1992)
  • K920604 — BIVONA TRACHEAL T-TUBE STENT (July 27, 1992)
  • K915761 — BIVONA-COLORADO VOICE PROSTHESIS (June 29, 1992)
  • K915799 — BIVONA SLEEP APNEA TUBE (February 3, 1992)

Other clearances for product code LWF

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  • K120665 — INVENT SNORING DEVICE (June 12, 2012)
  • K040491 — CHIN-UP STRIP (September 10, 2004)
  • K982929 — MAXAIR NASAL DILATOR SYSTEM (September 9, 1998)
  • K963326 — BREATHE FIT (February 12, 1997)
  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (September 9, 1996)
  • K962698 — ACUTEK'S CLEARPASAGE (September 9, 1996)
  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K955233 — EASY BREATHING NASAL STRIPS (December 21, 1995)