PuraDERM Gel
K-Number: K193085 · 2020-05-11
Device Summary
PuraDERM Gel is a medical device manufactured by 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2020-05-11 under approval number K193085. 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 PuraDERM Gel?
PuraDERM Gel is a medical device that received FDA 510(k) clearance on 2020-05-11. It is manufactured by 3-D Matrix, Inc.. The 510(k) number is K193085.
When was PuraDERM Gel approved by the FDA?
PuraDERM Gel received FDA 510(k) clearance on 2020-05-11, under approval number K193085.
What company makes PuraDERM Gel?
PuraDERM Gel is manufactured by 3-D Matrix, Inc..
What is the FDA product code for PuraDERM Gel?
The FDA product code for PuraDERM Gel is FRO. This falls under the Anesthesiology category.
Other Devices by 3-D Matrix, Inc.
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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.