NEOCERA Advanced Barrier Cream
K-Number: K170911 · 2017-08-22
ApplicantExeltis USA Dermatology, LLC
Decision Date2017-08-22
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
NEOCERA Advanced Barrier Cream is a medical device manufactured by Exeltis USA Dermatology, LLC. It received FDA 510(k) clearance on 2017-08-22 under approval number K170911. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NEOCERA Advanced Barrier Cream?
NEOCERA Advanced Barrier Cream is a medical device that received FDA 510(k) clearance on 2017-08-22. It is manufactured by Exeltis USA Dermatology, LLC. The 510(k) number is K170911.
When was NEOCERA Advanced Barrier Cream approved by the FDA?
NEOCERA Advanced Barrier Cream received FDA 510(k) clearance on 2017-08-22, under approval number K170911.
What company makes NEOCERA Advanced Barrier Cream?
NEOCERA Advanced Barrier Cream is manufactured by Exeltis USA Dermatology, LLC.
What is the FDA product code for NEOCERA Advanced Barrier Cream?
The FDA product code for NEOCERA Advanced Barrier Cream is FRO. This falls under the Anesthesiology category.
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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.