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510(k) K954914

BREATHE RIGHT NASAL STRIP by Cns, Inc. — Product Code LWF

K954914 is an FDA 510(k) premarket notification submitted by Cns, Inc. for the device "BREATHE RIGHT NASAL STRIP". The FDA issued a decision of Substantially Equivalent on February 27, 1996. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900. Cns, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1996
Date Received
October 26, 1995
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 Cns, Inc.

  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • K953772 — BREATHE RIGHT NASAL STRIP (October 20, 1995)
  • K950273 — SLEEP TEST(TM) (September 19, 1995)
  • K921220 — BREATHE RIGHT (October 7, 1993)
  • K912436 — AM-PAK (October 18, 1991)
  • K904432 — SLEEP I/T-5 AND SLEEP I/T-8 (July 10, 1991)
  • K910452 — RESPI-PAK RT-PAK (April 16, 1991)
  • K901549 — CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. (October 24, 1990)
  • K897107 — POLY G PHYSIOLOGICAL DATA RECORDER (March 12, 1990)
  • K860829 — CNS 4/8 AND CT 48.1 SOFTWARE (May 29, 1986)

Other clearances for product code LWF

  • K181219 — OptiPillows EPAP Mask (August 3, 2018)
  • 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)
  • K955233 — EASY BREATHING NASAL STRIPS (December 21, 1995)
  • K953042 — E-Z BREATHERS (December 8, 1995)

FDA data resources