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510(k) K142109

STERILUCENT STERILIZATION CONTAINER SYSTEM by Sterilucent, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2015
Date Received
August 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Sterilucent, Inc.

  • K192001 — Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process (October 22, 2019)
  • K191999 — Sterilucent VH2O2 Chemical Indicators (October 21, 2019)
  • K190005 — Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (September 13, 2019)
  • K141238 — STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR (November 3, 2014)
  • K141312 — STERILUCENT PROCESS CHALLENGE DEVICE (October 31, 2014)
  • K140464 — STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER (October 31, 2014)

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