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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 a medical device manufactured by Dong-A Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2022-04-21 under approval 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. It is manufactured by Dong-A Pharmaceutical Co., Ltd.. The 510(k) number is K212277.

When was Tempo Tampon approved by the FDA?

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

What company makes Tempo Tampon?

Tempo Tampon is manufactured by Dong-A Pharmaceutical Co., Ltd..

What is the FDA product code for Tempo Tampon?

The FDA product code for Tempo Tampon is HEB.

Other Devices by Dong-A Pharmaceutical Co., Ltd.

K212272Tempo Natural Tampon

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K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super PlFirst Quality Hygienic, Inc. K172118U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation K162746Ontex and other proprietary namesOntex Bvba K181911Interlude 100% Cotton TamponAlbaad Fem K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem

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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