DenMat Glutaraldehyde Desensitizer
K-Number: K222357 · 2022-08-09
ApplicantDenmat Holding, LLC
Decision Date2022-08-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DenMat Glutaraldehyde Desensitizer is a medical device manufactured by Denmat Holding, LLC. It received FDA 510(k) clearance on 2022-08-09 under approval number K222357. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DenMat Glutaraldehyde Desensitizer?
DenMat Glutaraldehyde Desensitizer is a medical device that received FDA 510(k) clearance on 2022-08-09. It is manufactured by Denmat Holding, LLC. The 510(k) number is K222357.
When was DenMat Glutaraldehyde Desensitizer approved by the FDA?
DenMat Glutaraldehyde Desensitizer received FDA 510(k) clearance on 2022-08-09, under approval number K222357.
What company makes DenMat Glutaraldehyde Desensitizer?
DenMat Glutaraldehyde Desensitizer is manufactured by Denmat Holding, LLC.
What is the FDA product code for DenMat Glutaraldehyde Desensitizer?
The FDA product code for DenMat Glutaraldehyde Desensitizer is KLE.
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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.