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510(k) K214096

Respire Clear by Respire Medical, LLC — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2022
Date Received
December 28, 2021
Clearance Type
Traditional
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 Respire Medical, LLC

  • K131138 — RESPIRE PINK SERIES - HERBST (September 9, 2013)
  • K111207 — RESPIRE BLUE SERIES (August 23, 2011)

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