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510(k) K192025

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader by Advanced Sterilization Products (Asp) — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2020
Date Received
July 29, 2019
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

Other clearances by Advanced Sterilization Products (Asp)

  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K182404 — STERRAD VELOCITY Biological Indicator (December 27, 2018)
  • K170039 — STERRAD VELOCITY Biological Indictator and Reader (June 20, 2017)
  • K152189 — EVOTECH ECR (July 20, 2016)

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