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FDA 510(k)

GuttaSil

K-Number: K190510 · 2019-05-29

ApplicantMeta Biomed Co., Ltd.
Decision Date2019-05-29
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GuttaSil is a medical device manufactured by Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2019-05-29 under approval number K190510. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GuttaSil?

GuttaSil is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Meta Biomed Co., Ltd.. The 510(k) number is K190510.

When was GuttaSil approved by the FDA?

GuttaSil received FDA 510(k) clearance on 2019-05-29, under approval number K190510.

What company makes GuttaSil?

GuttaSil is manufactured by Meta Biomed Co., Ltd..

What is the FDA product code for GuttaSil?

The FDA product code for GuttaSil is KIF.

Other Devices by Meta Biomed Co., Ltd.

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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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