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510(k) K191999

Sterilucent VH2O2 Chemical Indicators by Sterilucent, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2019
Date Received
July 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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  • K141312 — STERILUCENT PROCESS CHALLENGE DEVICE (October 31, 2014)
  • K140464 — STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER (October 31, 2014)

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