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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 a medical device manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-23 under approval 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. It is manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K182458.

When was Longterm NPWT Foam Dressing Kit approved by the FDA?

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

What company makes Longterm NPWT Foam Dressing Kit?

Longterm NPWT Foam Dressing Kit is manufactured by Zhejiang Longterm Medical Technology Co., Ltd..

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 Devices by Zhejiang Longterm Medical Technology Co., Ltd.

K192478LT Antibacterial Alginate with Silver Dressing K202823Innomed NPWT Silicone Foam Dressing K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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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