Home / 510(k) Clearances / K040491

510(k) K040491

CHIN-UP STRIP by Dale Miller, Inc. - the Chin-Up Company — Product Code LWF

K040491 is an FDA 510(k) premarket notification submitted by Dale Miller, Inc. - the Chin-Up Company for the device "CHIN-UP STRIP". The FDA issued a decision of Substantially Equivalent on September 10, 2004. 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 10, 2004
Date Received
February 26, 2004
Clearance Type
Abbreviated
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)
  • 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)
  • K953042 — E-Z BREATHERS (December 8, 1995)

FDA data resources