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FDA 510(k)

Protego Antimicrobial Wound Dressing

K-Number: K183681 · 2019-10-11

ApplicantGlobal Health Solutions (Dba Turn Therapeutics)
Decision Date2019-10-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Protego Antimicrobial Wound Dressing is a medical device manufactured by Global Health Solutions (Dba Turn Therapeutics). It received FDA 510(k) clearance on 2019-10-11 under approval number K183681. 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 Protego Antimicrobial Wound Dressing?

Protego Antimicrobial Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Global Health Solutions (Dba Turn Therapeutics). The 510(k) number is K183681.

When was Protego Antimicrobial Wound Dressing approved by the FDA?

Protego Antimicrobial Wound Dressing received FDA 510(k) clearance on 2019-10-11, under approval number K183681.

What company makes Protego Antimicrobial Wound Dressing?

Protego Antimicrobial Wound Dressing is manufactured by Global Health Solutions (Dba Turn Therapeutics).

What is the FDA product code for Protego Antimicrobial Wound Dressing?

The FDA product code for Protego Antimicrobial Wound Dressing is FRO. This falls under the Anesthesiology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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