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FDA 510(k)

Longterm NPWT Foam Dressing Kit

K-Number: K182458 · 2019-05-23

ApplicantZhejiang Longterm Medical Technology Co., Ltd.
Decision Date2019-05-23
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Longterm NPWT Foam Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K182458. 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 Longterm NPWT Foam Dressing Kit?

Longterm NPWT Foam Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K182458.

When did Longterm NPWT Foam Dressing Kit receive FDA 510(k) clearance?

Longterm NPWT Foam Dressing Kit received FDA 510(k) clearance on 2019-05-23, under 510(k) number K182458.

Who is the listed applicant for Longterm NPWT Foam Dressing Kit?

The FDA 510(k) record lists Zhejiang Longterm Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longterm NPWT Foam Dressing Kit?

The FDA product code for Longterm NPWT Foam Dressing Kit is OMP.

Other records listing Zhejiang Longterm Medical Technology Co., Ltd. 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.

K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitK202823Innomed NPWT Silicone Foam DressingK192478LT Antibacterial Alginate with Silver 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

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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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