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510(k) K882131

NOSE BRACE by Allied Advanced Technologies (Aat) — Product Code LWF

K882131 is an FDA 510(k) premarket notification submitted by Allied Advanced Technologies (Aat) for the device "NOSE BRACE". The FDA issued a decision of Substantially Equivalent on July 15, 1988. 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
July 15, 1988
Date Received
May 20, 1988
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

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  • 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