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510(k) K153291

SICAT OPTISLEEP by Sicat GmbH & Co. KG — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2016
Date Received
November 13, 2015
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 Sicat GmbH & Co. KG

  • K192348 — SICAT Implant V2.0 (December 4, 2019)
  • K180262 — SICAT Endo (March 12, 2018)
  • K143655 — SICAT OPTIMOTION (October 2, 2015)
  • K133320 — SICAT FUNCTION (February 25, 2014)
  • K103723 — SICAT IMPLANT V1.2 (May 20, 2011)
  • K093090 — GALILEOS IMPLANT, VERSION 1.7 (December 17, 2009)
  • K090119 — SICAT IMPLANT (February 5, 2009)
  • K061472 — GALILEOS IMPLANT, V 1.0 (June 9, 2006)

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