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510(k) K162816

SML-OSA2 Appliances by Selane Products, Inc. — Product Code LQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2017
Date Received
October 6, 2016
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.

  • K130130 — ATG/SM-OSA APPLIANCES (August 26, 2013)

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  • K192581 — The NightBlocks Appliance (January 28, 2020)
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  • 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)