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510(k) K140464

STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER by Sterilucent, Inc. — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2014
Date Received
February 24, 2014
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.

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  • K190005 — Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (September 13, 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)

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