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510(k) K213296

Anprolene SteriTest RRBI by Andersen Sterilizers, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2022
Date Received
October 1, 2021
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.

  • K202879 — EOGas 4 Endo-SteriTest RRBI (March 3, 2021)
  • K200334 — AN1036 Dosimeter (November 12, 2020)
  • K200335 — Sterisheet Sterilization Wrap (November 12, 2020)
  • K192980 — EOGas 4 Endo-SteriTest (November 12, 2020)
  • K200336 — Tyvek Sterilization Pouches with Chevron Seal (November 12, 2020)
  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170437 — Sterisheet Sterilization Wrap (November 1, 2017)
  • K170439 — AN87 Dosimeter (November 1, 2017)
  • K170427 — Anprolene SteriTest (October 31, 2017)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)

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