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FDA 510(k)

ETHYLENE OXIDE GAS STERILIZA SYS II

K-Number: K833457 · 1983-12-29

ApplicantBen Venue Laboratories, Inc.
Decision Date1983-12-29
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ETHYLENE OXIDE GAS STERILIZA SYS II is the device name listed in this FDA 510(k) record. The listed applicant is Ben Venue Laboratories, Inc.. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K833457. 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 ETHYLENE OXIDE GAS STERILIZA SYS II?

ETHYLENE OXIDE GAS STERILIZA SYS II is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Ben Venue Laboratories, Inc.. The 510(k) number is K833457.

When did ETHYLENE OXIDE GAS STERILIZA SYS II receive FDA 510(k) clearance?

ETHYLENE OXIDE GAS STERILIZA SYS II received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833457.

Who is the listed applicant for ETHYLENE OXIDE GAS STERILIZA SYS II?

The FDA 510(k) record lists Ben Venue Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHYLENE OXIDE GAS STERILIZA SYS II?

The FDA product code for ETHYLENE OXIDE GAS STERILIZA SYS II 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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