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510(k) K061228

FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR by Bryan Keropian Dds — Product Code LQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2006
Date Received
May 2, 2006
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 Bryan Keropian Dds

  • K091035 — FULL BREATH SLEEP APPLIANCE LOWER (FBSL) (June 24, 2009)
  • K053065 — FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BU (January 3, 2006)
  • K052862 — FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) (December 30, 2005)

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