Signum opaque F
K-Number: K230644 · 2023-09-07
ApplicantKulzer, LLC
Decision Date2023-09-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Signum opaque F is a medical device manufactured by Kulzer, LLC. It received FDA 510(k) clearance on 2023-09-07 under approval number K230644. 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 Signum opaque F?
Signum opaque F is a medical device that received FDA 510(k) clearance on 2023-09-07. It is manufactured by Kulzer, LLC. The 510(k) number is K230644.
When was Signum opaque F approved by the FDA?
Signum opaque F received FDA 510(k) clearance on 2023-09-07, under approval number K230644.
What company makes Signum opaque F?
Signum opaque F is manufactured by Kulzer, LLC.
What is the FDA product code for Signum opaque F?
The FDA product code for Signum opaque F 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.