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FDA 510(k)

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM

K-Number: K014013 · 2003-06-25

ApplicantH & W Technology, LLC
Decision Date2003-06-25
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is H & W Technology, LLC. It received FDA 510(k) clearance on 2003-06-25 under 510(k) number K014013. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM?

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is H & W Technology, LLC. The 510(k) number is K014013.

When did H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM receive FDA 510(k) clearance?

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM received FDA 510(k) clearance on 2003-06-25, under 510(k) number K014013.

Who is the listed applicant for H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM?

The FDA 510(k) record lists H & W Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM?

The FDA product code for H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM is FLF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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