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FDA 510(k)

BIAFINE

K-Number: K173549 · 2018-08-13

ApplicantValeant Pharmaceuticals
Decision Date2018-08-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BIAFINE is the device name listed in this FDA 510(k) record. The listed applicant is Valeant Pharmaceuticals. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K173549. 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 BIAFINE?

BIAFINE is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Valeant Pharmaceuticals. The 510(k) number is K173549.

When did BIAFINE receive FDA 510(k) clearance?

BIAFINE received FDA 510(k) clearance on 2018-08-13, under 510(k) number K173549.

Who is the listed applicant for BIAFINE?

The FDA 510(k) record lists Valeant Pharmaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIAFINE?

The FDA product code for BIAFINE is FRO. This falls under the Anesthesiology category.

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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