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FDA 510(k)

Next Science Wound Gel (Rx)

K-Number: K163188 · 2017-03-06

Decision Date2017-03-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Next Science Wound Gel (Rx) is a medical device manufactured by Next Science, LLC. It received FDA 510(k) clearance on 2017-03-06 under approval number K163188. 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 Next Science Wound Gel (Rx)?

Next Science Wound Gel (Rx) is a medical device that received FDA 510(k) clearance on 2017-03-06. It is manufactured by Next Science, LLC. The 510(k) number is K163188.

When was Next Science Wound Gel (Rx) approved by the FDA?

Next Science Wound Gel (Rx) received FDA 510(k) clearance on 2017-03-06, under approval number K163188.

What company makes Next Science Wound Gel (Rx)?

Next Science Wound Gel (Rx) is manufactured by Next Science, LLC.

What is the FDA product code for Next Science Wound Gel (Rx)?

The FDA product code for Next Science Wound Gel (Rx) is FRO. This falls under the Anesthesiology category.

Related PubMed Literature

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Official Source

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