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510(k) K982929

MAXAIR NASAL DILATOR SYSTEM by Hnl Technologies — Product Code LWF

K982929 is an FDA 510(k) premarket notification submitted by Hnl Technologies for the device "MAXAIR NASAL DILATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 9, 1998. 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 9, 1998
Date Received
August 20, 1998
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)
  • 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)
  • K953042 — E-Z BREATHERS (December 8, 1995)

FDA data resources