Home / 510(k) Clearances / K032410

510(k) K032410

SNORENTI by James P Boyd — Product Code LQZ

K032410 is an FDA 510(k) premarket notification submitted by James P Boyd for the device "SNORENTI". The FDA issued a decision of Substantially Equivalent on February 28, 2005. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2005
Date Received
August 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Jaw Repositioning
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances for product code LQZ

  • K233754 — AIO Breathe (February 23, 2024)
  • K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea (July 12, 2023)
  • K203712 — The Slide (July 20, 2021)
  • K191320 — Slow Wave DS8 (October 2, 2020)
  • K192581 — The NightBlocks Appliance (January 28, 2020)
  • K162816 — SML-OSA2 Appliances (July 27, 2017)
  • K130130 — ATG/SM-OSA APPLIANCES (August 26, 2013)
  • K112627 — MILLENIUM ANTI-SNORING DEVICE (June 6, 2012)
  • K112766 — SNORKEL (June 4, 2012)
  • K113201 — NARVAL CC (December 1, 2011)

FDA data resources