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510(k) K202879

EOGas 4 Endo-SteriTest RRBI by Andersen Sterilizers, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2021
Date Received
September 28, 2020
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 Andersen Sterilizers, Inc.

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  • K200336 — Tyvek Sterilization Pouches with Chevron Seal (November 12, 2020)
  • K200334 — AN1036 Dosimeter (November 12, 2020)
  • K192980 — EOGas 4 Endo-SteriTest (November 12, 2020)
  • K170437 — Sterisheet Sterilization Wrap (November 1, 2017)
  • K170439 — AN87 Dosimeter (November 1, 2017)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K170427 — Anprolene SteriTest (October 31, 2017)

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