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FDA 510(k)

WELLGRAFT PE II

K-Number: K072170 · 2008-04-04

ApplicantGwowei Technology Co., Ltd.
Decision Date2008-04-04
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WELLGRAFT PE II is the device name listed in this FDA 510(k) record. The listed applicant is Gwowei Technology Co., Ltd.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K072170. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLGRAFT PE II?

WELLGRAFT PE II is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Gwowei Technology Co., Ltd.. The 510(k) number is K072170.

When did WELLGRAFT PE II receive FDA 510(k) clearance?

WELLGRAFT PE II received FDA 510(k) clearance on 2008-04-04, under 510(k) number K072170.

Who is the listed applicant for WELLGRAFT PE II?

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

What is the FDA product code for WELLGRAFT PE II?

The FDA product code for WELLGRAFT PE II is MQV.

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Other records listing Gwowei 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.

K072444WELLGRAFT PE I

Related Devices (Code: MQV)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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