Dakin's Skin and Wound Cleanser
K-Number: K150208 · 2016-07-21
ApplicantCentury Pharmaceuticals, Inc.
Decision Date2016-07-21
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Dakin's Skin and Wound Cleanser is a medical device manufactured by Century Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2016-07-21 under approval number K150208. 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 Dakin's Skin and Wound Cleanser?
Dakin's Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Century Pharmaceuticals, Inc.. The 510(k) number is K150208.
When was Dakin's Skin and Wound Cleanser approved by the FDA?
Dakin's Skin and Wound Cleanser received FDA 510(k) clearance on 2016-07-21, under approval number K150208.
What company makes Dakin's Skin and Wound Cleanser?
Dakin's Skin and Wound Cleanser is manufactured by Century Pharmaceuticals, Inc..
What is the FDA product code for Dakin's Skin and Wound Cleanser?
The FDA product code for Dakin's Skin and Wound Cleanser 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.