Gradia Plus
K-Number: K153325 · 2016-07-12
ApplicantGC America, Inc.
Decision Date2016-07-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Gradia Plus is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-07-12 under approval number K153325. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gradia Plus?
Gradia Plus is a medical device that received FDA 510(k) clearance on 2016-07-12. It is manufactured by GC America, Inc.. The 510(k) number is K153325.
When was Gradia Plus approved by the FDA?
Gradia Plus received FDA 510(k) clearance on 2016-07-12, under approval number K153325.
What company makes Gradia Plus?
Gradia Plus is manufactured by GC America, Inc..
What is the FDA product code for Gradia Plus?
The FDA product code for Gradia Plus is EBF.
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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.