Calcium Bridge
K-Number: K153191 · 2016-02-26
ApplicantDenali Corporation
Decision Date2016-02-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Calcium Bridge is a medical device manufactured by Denali Corporation. It received FDA 510(k) clearance on 2016-02-26 under approval number K153191. 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 Calcium Bridge?
Calcium Bridge is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Denali Corporation. The 510(k) number is K153191.
When was Calcium Bridge approved by the FDA?
Calcium Bridge received FDA 510(k) clearance on 2016-02-26, under approval number K153191.
What company makes Calcium Bridge?
Calcium Bridge is manufactured by Denali Corporation.
What is the FDA product code for Calcium Bridge?
The FDA product code for Calcium Bridge 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.