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FDA 510(k)

Meta P&Bond

K-Number: K180802 · 2018-08-29

ApplicantMeta Biomed Co., Ltd.
Decision Date2018-08-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Meta P&Bond is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K180802. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Meta P&Bond?

Meta P&Bond is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K180802.

When did Meta P&Bond receive FDA 510(k) clearance?

Meta P&Bond received FDA 510(k) clearance on 2018-08-29, under 510(k) number K180802.

Who is the listed applicant for Meta P&Bond?

The FDA 510(k) record lists Meta Biomed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Meta P&Bond?

The FDA product code for Meta P&Bond is KLE.

Other records listing Meta Biomed Co., Ltd. as applicant

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Related Devices (Code: KLE)

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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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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