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FDA 510(k)

FEMME Applicator Tampon

K-Number: K182142 · 2019-08-28

ApplicantJiangsu Yoai Technology Co., Ltd.
Decision Date2019-08-28
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMME Applicator Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yoai Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K182142. 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 FEMME Applicator Tampon?

FEMME Applicator Tampon is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Jiangsu Yoai Technology Co., Ltd.. The 510(k) number is K182142.

When did FEMME Applicator Tampon receive FDA 510(k) clearance?

FEMME Applicator Tampon received FDA 510(k) clearance on 2019-08-28, under 510(k) number K182142.

Who is the listed applicant for FEMME Applicator Tampon?

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

What is the FDA product code for FEMME Applicator Tampon?

The FDA product code for FEMME Applicator Tampon is HEB.

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.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.

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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