Family of Steam Sterilizers B 28 series
K-Number: K151597 · 2016-03-04
ApplicantCefla S.C.
Decision Date2016-03-04
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Family of Steam Sterilizers B 28 series is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2016-03-04 under approval number K151597. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Family of Steam Sterilizers B 28 series?
Family of Steam Sterilizers B 28 series is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Cefla S.C.. The 510(k) number is K151597.
When was Family of Steam Sterilizers B 28 series approved by the FDA?
Family of Steam Sterilizers B 28 series received FDA 510(k) clearance on 2016-03-04, under approval number K151597.
What company makes Family of Steam Sterilizers B 28 series?
Family of Steam Sterilizers B 28 series is manufactured by Cefla S.C..
What is the FDA product code for Family of Steam Sterilizers B 28 series?
The FDA product code for Family of Steam Sterilizers B 28 series is FLE.
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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.