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510(k) K170427

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2017
Date Received
February 13, 2017
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.

  • K213296 — Anprolene SteriTest RRBI (April 12, 2022)
  • K202879 — EOGas 4 Endo-SteriTest RRBI (March 3, 2021)
  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K200335 — Sterisheet Sterilization Wrap (November 12, 2020)
  • 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)

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