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FDA 510(k)

Youjia Unscented Tampon with Plastic Applicators

K-Number: K192557 · 2020-02-13

Decision Date2020-02-13
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Youjia Unscented Tampon with Plastic Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Youjia Hygiene Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192557. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Youjia Unscented Tampon with Plastic Applicators?

Youjia Unscented Tampon with Plastic Applicators is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Qingdao Youjia Hygiene Technology Co., Ltd.. The 510(k) number is K192557.

When did Youjia Unscented Tampon with Plastic Applicators receive FDA 510(k) clearance?

Youjia Unscented Tampon with Plastic Applicators received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192557.

Who is the listed applicant for Youjia Unscented Tampon with Plastic Applicators?

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

What is the FDA product code for Youjia Unscented Tampon with Plastic Applicators?

The FDA product code for Youjia Unscented Tampon with Plastic Applicators is HEB.

Other records listing Qingdao Youjia Hygiene 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.

Related Devices (Code: HEB)

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.

Official Source

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