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510(k) K083209

ACRYLIC HERBST SPLINT APPLIANCE by Specialty Appliance Works, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2009
Date Received
October 31, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Specialty Appliance Works, Inc.

  • K183643 — Clear Image Aligners (January 3, 2019)
  • K071970 — CLEAR IMAGE ALIGNER (September 25, 2007)

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