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FDA 510(k)

ACRYDERM ABSORBENT OXYGEN DRESSING

K-Number: K082459 · 2008-09-19

ApplicantAcrymed, Inc.
Decision Date2008-09-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACRYDERM ABSORBENT OXYGEN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Acrymed, Inc.. It received FDA 510(k) clearance on 2008-09-19 under 510(k) number K082459. 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 ACRYDERM ABSORBENT OXYGEN DRESSING?

ACRYDERM ABSORBENT OXYGEN DRESSING is a medical device that received FDA 510(k) clearance on 2008-09-19. The listed applicant is Acrymed, Inc.. The 510(k) number is K082459.

When did ACRYDERM ABSORBENT OXYGEN DRESSING receive FDA 510(k) clearance?

ACRYDERM ABSORBENT OXYGEN DRESSING received FDA 510(k) clearance on 2008-09-19, under 510(k) number K082459.

Who is the listed applicant for ACRYDERM ABSORBENT OXYGEN DRESSING?

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

What is the FDA product code for ACRYDERM ABSORBENT OXYGEN DRESSING?

The FDA product code for ACRYDERM ABSORBENT OXYGEN DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Acrymed, Inc. 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.

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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