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FDA 510(k)

Tempo Tampon

K-Number: K212277 · 2022-04-21

ApplicantDong-A Pharmaceutical Co., Ltd.
Decision Date2022-04-21
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Tempo 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 2022-04-21 under 510(k) number K212277. 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 Tampon?

Tempo Tampon is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Dong-A Pharmaceutical Co., Ltd.. The 510(k) number is K212277.

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

Tempo Tampon received FDA 510(k) clearance on 2022-04-21, under 510(k) number K212277.

Who is the listed applicant for Tempo 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 Tampon?

The FDA product code for Tempo 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.

K212272Tempo Natural 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

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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