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510(k) K133320

SICAT FUNCTION by Sicat GmbH & Co. KG — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2014
Date Received
October 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Sicat GmbH & Co. KG

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  • K180262 — SICAT Endo (March 12, 2018)
  • K153291 — SICAT OPTISLEEP (March 31, 2016)
  • K143655 — SICAT OPTIMOTION (October 2, 2015)
  • 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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