LUOFUCON Silicone Ag Foam Dressing with Border
K-Number: K170077 · 2017-03-30
Decision Date2017-03-30
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
LUOFUCON Silicone Ag Foam Dressing with Border is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-03-30 under approval number K170077. 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 LUOFUCON Silicone Ag Foam Dressing with Border?
LUOFUCON Silicone Ag Foam Dressing with Border is a medical device that received FDA 510(k) clearance on 2017-03-30. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K170077.
When was LUOFUCON Silicone Ag Foam Dressing with Border approved by the FDA?
LUOFUCON Silicone Ag Foam Dressing with Border received FDA 510(k) clearance on 2017-03-30, under approval number K170077.
What company makes LUOFUCON Silicone Ag Foam Dressing with Border?
LUOFUCON Silicone Ag Foam Dressing with Border is manufactured by Huizhou Foryou Medical Devices Co., Ltd..
What is the FDA product code for LUOFUCON Silicone Ag Foam Dressing with Border?
The FDA product code for LUOFUCON Silicone Ag Foam Dressing with Border 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.