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510(k) K960673

OSAP by Snorefree, Inc. — Product Code LQZ

K960673 is an FDA 510(k) premarket notification submitted by Snorefree, Inc. for the device "OSAP". The FDA issued a decision of Substantially Equivalent on May 9, 1996. 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
May 9, 1996
Date Received
February 20, 1996
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

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  • 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