Home / 510(k) Clearances / K962400

510(k) K962400

AIR MAX EXTERNAL NASAL DILATOR STRIP by American White Cross, Inc. — Product Code LWF

K962400 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "AIR MAX EXTERNAL NASAL DILATOR STRIP". The FDA issued a decision of Substantially Equivalent on September 9, 1996. The device falls under product code LWF (Dilator, Nasal), a Class I device regulated under 21 CFR 874.3900. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1996
Date Received
June 21, 1996
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 American White Cross, Inc.

  • K964614 — ULTRAFERA WOUND DRESSING (February 6, 1997)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K854809 — WHITE CROSS STERILE PAD 4IN. X 4IN. (January 13, 1986)
  • K853558 — DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ (September 5, 1985)
  • K853334 — NON-ADHERA ADHESIVE PAD 3X4 (August 21, 1985)
  • K852408 — EXTRA LARGE ADHESIVE STRIPS (July 29, 1985)
  • K852412 — NON-ADHERENT PAD (July 29, 1985)
  • K852462 — TRICOT ADHESIVE BANDAGE (July 26, 1985)
  • K850595 — 3 X 4 NON-ADHERENT PAD (March 11, 1985)

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)
  • 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