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510(k) K014013

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM by H & W Technology, LLC — Product Code FLF

K014013 is an FDA 510(k) premarket notification submitted by H & W Technology, LLC for the device "H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 2003. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2003
Date Received
December 5, 2001
Clearance Type
Abbreviated
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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  • 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)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

FDA data resources