FDA 510(k)

SupraSDRM Biodegradable Matrix Wound Dressing

Numéro K : K170213 · 2017-06-28

Date de décision2017-06-28

Code produitQSZ

DécisionSubstantially Equivalent

Résumé du dispositif

SupraSDRM Biodegradable Matrix Wound 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 2017-06-28 under 510(k) number K170213. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SupraSDRM Biodegradable Matrix Wound Dressing?

SupraSDRM Biodegradable Matrix Wound Dressing is a medical device that received FDA 510(k) clearance on 2017-06-28. The listed applicant is Polymedics Innovations, GmbH. The 510(k) number is K170213.

When did SupraSDRM Biodegradable Matrix Wound Dressing receive FDA 510(k) clearance?

SupraSDRM Biodegradable Matrix Wound Dressing received FDA 510(k) clearance on 2017-06-28, under 510(k) number K170213.

Who is the listed applicant for SupraSDRM Biodegradable Matrix Wound 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 SupraSDRM Biodegradable Matrix Wound Dressing?

The FDA product code for SupraSDRM Biodegradable Matrix Wound Dressing is QSZ.

Essais cliniques associés

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Dispositifs connexes (Code : QSZ)

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

Source officielle

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