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FDA 510(k)

Innomed NPWT Silicone Foam Dressing

K-Number: K202823 · 2021-12-15

ApplicantZhejiang Longterm Medical Technology Co., Ltd.
Decision Date2021-12-15
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Innomed NPWT Silicone Foam Dressing is a medical device manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under approval number K202823. 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 Innomed NPWT Silicone Foam Dressing?

Innomed NPWT Silicone Foam Dressing is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K202823.

When was Innomed NPWT Silicone Foam Dressing approved by the FDA?

Innomed NPWT Silicone Foam Dressing received FDA 510(k) clearance on 2021-12-15, under approval number K202823.

What company makes Innomed NPWT Silicone Foam Dressing?

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

What is the FDA product code for Innomed NPWT Silicone Foam Dressing?

The FDA product code for Innomed NPWT Silicone Foam Dressing is OMP.

Other Devices by Zhejiang Longterm Medical Technology Co., Ltd.

K182458Longterm NPWT Foam Dressing Kit K192478LT Antibacterial Alginate with Silver 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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