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510(k) K170432

Anprolene AN75 Ethylene Oxide Gas Sterilizer by Andersen Sterilizers, Inc. — Product Code FLF

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
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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  • K170437 — Sterisheet Sterilization Wrap (November 1, 2017)
  • K170439 — AN87 Dosimeter (November 1, 2017)
  • K170427 — Anprolene SteriTest (October 31, 2017)

Other clearances for product code FLF

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  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
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  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)