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510(k) K152058

Tyvek Sterilization Pouches with Chevron Seal by Andersen Sterilizers, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2015
Date Received
July 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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

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  • K242898 — Sterilization Pouches and Reels (February 21, 2025)