Anprolene AN75 Ethylene Oxide Gas Sterilizer
K-Number: K170432 · 2017-10-31
ApplicantAndersen Sterilizers, Inc.
Decision Date2017-10-31
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Anprolene AN75 Ethylene Oxide Gas Sterilizer is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-10-31 under approval number K170432. 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 Anprolene AN75 Ethylene Oxide Gas Sterilizer?
Anprolene AN75 Ethylene Oxide Gas Sterilizer is a medical device that received FDA 510(k) clearance on 2017-10-31. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K170432.
When was Anprolene AN75 Ethylene Oxide Gas Sterilizer approved by the FDA?
Anprolene AN75 Ethylene Oxide Gas Sterilizer received FDA 510(k) clearance on 2017-10-31, under approval number K170432.
What company makes Anprolene AN75 Ethylene Oxide Gas Sterilizer?
Anprolene AN75 Ethylene Oxide Gas Sterilizer is manufactured by Andersen Sterilizers, Inc..
What is the FDA product code for Anprolene AN75 Ethylene Oxide Gas Sterilizer?
The FDA product code for Anprolene AN75 Ethylene Oxide Gas Sterilizer is FLF.
Related PubMed Literature
Other Devices by Andersen Sterilizers, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.