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FDA 510(k)

ALBA HEALTH CARE NON-ADHERING DRESSING

K-Number: K850241 · 1985-03-12

ApplicantAlba Health Care
Decision Date1985-03-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ALBA HEALTH CARE NON-ADHERING DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Alba Health Care. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K850241. 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 ALBA HEALTH CARE NON-ADHERING DRESSING?

ALBA HEALTH CARE NON-ADHERING DRESSING is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Alba Health Care. The 510(k) number is K850241.

When did ALBA HEALTH CARE NON-ADHERING DRESSING receive FDA 510(k) clearance?

ALBA HEALTH CARE NON-ADHERING DRESSING received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850241.

Who is the listed applicant for ALBA HEALTH CARE NON-ADHERING DRESSING?

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

What is the FDA product code for ALBA HEALTH CARE NON-ADHERING DRESSING?

The FDA product code for ALBA HEALTH CARE NON-ADHERING DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Alba Health Care 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.

K864689ALBA HEALTH CARE IODOFORM PACKING STRIPK861154ALBA HEALTH CARE PLAIN PACKING STRIPK851918INFANT PHOTOTHERAPY MASKK850881ALBA DRY BURN PADK850904ALBA DRY BURN DRESSINGK812904STERILE ORTHOPEDIC STOCKINETTE

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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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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