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FDA 510(k)

PWD Platform Wound Dressing 3” x 5” Oblong

K-Number: K191460 · 2019-07-02

ApplicantApplied Tissue Technologies, LLC
Decision Date2019-07-02
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PWD Platform Wound Dressing 3” x 5” Oblong is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K191460. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PWD Platform Wound Dressing 3” x 5” Oblong?

PWD Platform Wound Dressing 3” x 5” Oblong is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K191460.

When did PWD Platform Wound Dressing 3” x 5” Oblong receive FDA 510(k) clearance?

PWD Platform Wound Dressing 3” x 5” Oblong received FDA 510(k) clearance on 2019-07-02, under 510(k) number K191460.

Who is the listed applicant for PWD Platform Wound Dressing 3” x 5” Oblong?

The FDA 510(k) record lists Applied Tissue Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong?

The FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong is OMP.

Other records listing Applied Tissue Technologies, LLC 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.

K212359PWD Negative Pressure Wound Therapy SystemK182409Applied Tissue Technologies PWD™ Platform Wound Dressing

Related Devices (Code: OMP)

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.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, 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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