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510(k) K130130

ATG/SM-OSA APPLIANCES by Selane Products, Inc. — Product Code LQZ

K130130 is an FDA 510(k) premarket notification submitted by Selane Products, Inc. for the device "ATG/SM-OSA APPLIANCES". The FDA issued a decision of Substantially Equivalent on August 26, 2013. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Selane Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2013
Date Received
January 17, 2013
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 by Selane Products, Inc.

  • K162816 — SML-OSA2 Appliances (July 27, 2017)

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)
  • K112627 — MILLENIUM ANTI-SNORING DEVICE (June 6, 2012)
  • K112766 — SNORKEL (June 4, 2012)
  • K113201 — NARVAL CC (December 1, 2011)
  • K090911 — IST SNORING APPLIANCE (September 11, 2009)

FDA data resources