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510(k) K921220

BREATHE RIGHT by Cns, Inc. — Product Code LWF

K921220 is an FDA 510(k) premarket notification submitted by Cns, Inc. for the device "BREATHE RIGHT". The FDA issued a decision of Substantially Equivalent on October 7, 1993. 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
October 7, 1993
Date Received
March 13, 1992
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)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K953772 — BREATHE RIGHT NASAL STRIP (October 20, 1995)
  • K950273 — SLEEP TEST(TM) (September 19, 1995)
  • 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)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K955233 — EASY BREATHING NASAL STRIPS (December 21, 1995)

FDA data resources