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FDA 510(k)

HYALURONIC ACID TOPICAL WOUND CREAM

K-Number: K172747 · 2018-04-27

ApplicantVirchow Biotech Pvt, Ltd.
Decision Date2018-04-27
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYALURONIC ACID TOPICAL WOUND CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Virchow Biotech Pvt, Ltd.. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172747. 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 HYALURONIC ACID TOPICAL WOUND CREAM?

HYALURONIC ACID TOPICAL WOUND CREAM is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Virchow Biotech Pvt, Ltd.. The 510(k) number is K172747.

When did HYALURONIC ACID TOPICAL WOUND CREAM receive FDA 510(k) clearance?

HYALURONIC ACID TOPICAL WOUND CREAM received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172747.

Who is the listed applicant for HYALURONIC ACID TOPICAL WOUND CREAM?

The FDA 510(k) record lists Virchow Biotech Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYALURONIC ACID TOPICAL WOUND CREAM?

The FDA product code for HYALURONIC ACID TOPICAL WOUND CREAM is FRO. This falls under the Anesthesiology category.

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Other records listing Virchow Biotech Pvt, Ltd. 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.

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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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