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FDA 510(k)

Unscented Tampon

K-Number: K241064 · 2025-01-10

ApplicantShandong Intco Hygiene Products Co., Ltd.
Decision Date2025-01-10
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unscented Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Intco Hygiene Products Co., Ltd.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241064. 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 Unscented Tampon?

Unscented Tampon is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Shandong Intco Hygiene Products Co., Ltd.. The 510(k) number is K241064.

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

Unscented Tampon received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241064.

Who is the listed applicant for Unscented Tampon?

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

What is the FDA product code for Unscented Tampon?

The FDA product code for Unscented 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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