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FDA 510(k)

SUPRATHEL WOUND AND BURN DRESSING

K-Number: K090160 · 2009-05-20

ApplicantPolymedics Innovations, GmbH
Decision Date2009-05-20
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

SUPRATHEL WOUND AND BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Polymedics Innovations, GmbH. It received FDA 510(k) clearance on 2009-05-20 under 510(k) number K090160. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPRATHEL WOUND AND BURN DRESSING?

SUPRATHEL WOUND AND BURN DRESSING is a medical device that received FDA 510(k) clearance on 2009-05-20. The listed applicant is Polymedics Innovations, GmbH. The 510(k) number is K090160.

When did SUPRATHEL WOUND AND BURN DRESSING receive FDA 510(k) clearance?

SUPRATHEL WOUND AND BURN DRESSING received FDA 510(k) clearance on 2009-05-20, under 510(k) number K090160.

Who is the listed applicant for SUPRATHEL WOUND AND BURN DRESSING?

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

What is the FDA product code for SUPRATHEL WOUND AND BURN DRESSING?

The FDA product code for SUPRATHEL WOUND AND BURN DRESSING is QSZ.

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Other records listing Polymedics Innovations, GmbH 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.

K170213SupraSDRM Biodegradable Matrix Wound Dressing

Related Devices (Code: QSZ)

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.

K261311HYALOMATRIXAnika Therapeutics, Inc.K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K241660SiOxD® Wound MatrixSioxmed, LLC

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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