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FDA 510(k)

Dash-Topic Plus Cream

K-Number: K150914 · 2016-04-21

ApplicantFounders Science Group, LLC
Decision Date2016-04-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Dash-Topic Plus Cream is the device name listed in this FDA 510(k) record. The listed applicant is Founders Science Group, LLC. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K150914. 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 Dash-Topic Plus Cream?

Dash-Topic Plus Cream is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Founders Science Group, LLC. The 510(k) number is K150914.

When did Dash-Topic Plus Cream receive FDA 510(k) clearance?

Dash-Topic Plus Cream received FDA 510(k) clearance on 2016-04-21, under 510(k) number K150914.

Who is the listed applicant for Dash-Topic Plus Cream?

The FDA 510(k) record lists Founders Science Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dash-Topic Plus Cream?

The FDA product code for Dash-Topic Plus Cream is FRO. This falls under the Anesthesiology category.

Other records listing Founders Science Group, LLC as applicant

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.

K171879HylaGuard Moisturizing Cream

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

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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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