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510(k) K862406

NOZEES NOSTRIL DILATOR by Nozees Co. — Product Code LWF

K862406 is an FDA 510(k) premarket notification submitted by Nozees Co. for the device "NOZEES NOSTRIL DILATOR". The FDA issued a decision of Substantially Equivalent on September 19, 1986. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1986
Date Received
June 25, 1986
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 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