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FDA 510(k)

Sequel Tampon with Plastic Applicator

K-Number: K230419 · 2023-08-03

ApplicantTampro, Inc.
Decision Date2023-08-03
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sequel Tampon with Plastic Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Tampro, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K230419. 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 Sequel Tampon with Plastic Applicator?

Sequel Tampon with Plastic Applicator is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Tampro, Inc.. The 510(k) number is K230419.

When did Sequel Tampon with Plastic Applicator receive FDA 510(k) clearance?

Sequel Tampon with Plastic Applicator received FDA 510(k) clearance on 2023-08-03, under 510(k) number K230419.

Who is the listed applicant for Sequel Tampon with Plastic Applicator?

The FDA 510(k) record lists Tampro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sequel Tampon with Plastic Applicator?

The FDA product code for Sequel Tampon with Plastic Applicator 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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