ETIII SA Fixture System (O3.2mm)
K-Number: K153332 · 2016-10-27
ApplicantHiossen, Inc.
Decision Date2016-10-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ETIII SA Fixture System (O3.2mm) is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2016-10-27 under approval number K153332. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ETIII SA Fixture System (O3.2mm)?
ETIII SA Fixture System (O3.2mm) is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Hiossen, Inc.. The 510(k) number is K153332.
When was ETIII SA Fixture System (O3.2mm) approved by the FDA?
ETIII SA Fixture System (O3.2mm) received FDA 510(k) clearance on 2016-10-27, under approval number K153332.
What company makes ETIII SA Fixture System (O3.2mm)?
ETIII SA Fixture System (O3.2mm) is manufactured by Hiossen, Inc..
What is the FDA product code for ETIII SA Fixture System (O3.2mm)?
The FDA product code for ETIII SA Fixture System (O3.2mm) is DZE.
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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.