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FDA 510(k)

Tempo Natural Tampon

K-Number: K212272 · 2021-09-17

ApplicantDong-A Pharmaceutical Co., Ltd.
Decision Date2021-09-17
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Tempo Natural Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Dong-A Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K212272. 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 Tempo Natural Tampon?

Tempo Natural Tampon is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Dong-A Pharmaceutical Co., Ltd.. The 510(k) number is K212272.

When did Tempo Natural Tampon receive FDA 510(k) clearance?

Tempo Natural Tampon received FDA 510(k) clearance on 2021-09-17, under 510(k) number K212272.

Who is the listed applicant for Tempo Natural Tampon?

The FDA 510(k) record lists Dong-A Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempo Natural Tampon?

The FDA product code for Tempo Natural Tampon is HEB.

Other records listing Dong-A Pharmaceutical 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.

K212277Tempo Tampon

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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