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510(k) K030440

OASYS-ORAL AIRWAY SYSTEM by Mark Abramson, D.D.S., Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2003
Date Received
February 11, 2003
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 Mark Abramson, D.D.S., Inc.

  • K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (April 19, 2019)

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