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510(k) K141312

STERILUCENT PROCESS CHALLENGE DEVICE by Sterilucent, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2014
Date Received
May 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K141238 — STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR (November 3, 2014)
  • K140464 — STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER (October 31, 2014)

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