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510(k) K190005

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer by Sterilucent, Inc. — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2019
Date Received
January 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
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)
  • K142109 — STERILUCENT STERILIZATION CONTAINER SYSTEM (January 20, 2015)
  • 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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