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FDA 510(k)

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

K-Number: K211571 · 2022-05-31

ApplicantZhejiang Longterm Medical Technology Co., Ltd.
Decision Date2022-05-31
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam 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 2022-05-31 under 510(k) number K211571. 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 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K211571.

When did Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit receive FDA 510(k) clearance?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit received FDA 510(k) clearance on 2022-05-31, under 510(k) number K211571.

Who is the listed applicant for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam 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 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

The FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is OMP.

Related Clinical Trials

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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.

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Related Devices (Code: OMP)

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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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