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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 the device name listed in this FDA 510(k) record. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). It received FDA 510(k) clearance on 2019-10-11 under 510(k) 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. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). The 510(k) number is K183681.

When did Protego Antimicrobial Wound Dressing receive FDA 510(k) clearance?

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

Who is the listed applicant for Protego Antimicrobial Wound Dressing?

The FDA 510(k) record lists Global Health Solutions (Dba Turn Therapeutics) as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06011603Prineo Sensitivity Dressing StudyCOMPLETEDNCT07066254The Mepilex Cesarean Delivery TrialWITHDRAWNNCT07494773Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound InfectionNOT_YET_RECRUITINGNCT07758855Nanotechnological Silver-Coated Dressing in Diabetic Foot UlcersCOMPLETED

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.

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