Lumina-PTFE Titanium
K-Number: K221851 · 2023-12-08
Decision Date2023-12-08
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lumina-PTFE Titanium is a medical device manufactured by Criteria Industria E Comercio DE Produtos Medicinais. It received FDA 510(k) clearance on 2023-12-08 under approval number K221851. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lumina-PTFE Titanium?
Lumina-PTFE Titanium is a medical device that received FDA 510(k) clearance on 2023-12-08. It is manufactured by Criteria Industria E Comercio DE Produtos Medicinais. The 510(k) number is K221851.
When was Lumina-PTFE Titanium approved by the FDA?
Lumina-PTFE Titanium received FDA 510(k) clearance on 2023-12-08, under approval number K221851.
What company makes Lumina-PTFE Titanium?
Lumina-PTFE Titanium is manufactured by Criteria Industria E Comercio DE Produtos Medicinais.
What is the FDA product code for Lumina-PTFE Titanium?
The FDA product code for Lumina-PTFE Titanium is NPK.
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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.