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FDA 510(k)

Interlude Rolled Tampons in Plastic Applicator

K-Number: K191431 · 2019-10-07

ApplicantAlbaad Fem
Decision Date2019-10-07
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Interlude Rolled Tampons in Plastic Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Albaad Fem. It received FDA 510(k) clearance on 2019-10-07 under 510(k) number K191431. 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 Interlude Rolled Tampons in Plastic Applicator?

Interlude Rolled Tampons in Plastic Applicator is a medical device that received FDA 510(k) clearance on 2019-10-07. The listed applicant is Albaad Fem. The 510(k) number is K191431.

When did Interlude Rolled Tampons in Plastic Applicator receive FDA 510(k) clearance?

Interlude Rolled Tampons in Plastic Applicator received FDA 510(k) clearance on 2019-10-07, under 510(k) number K191431.

Who is the listed applicant for Interlude Rolled Tampons in Plastic Applicator?

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

What is the FDA product code for Interlude Rolled Tampons in Plastic Applicator?

The FDA product code for Interlude Rolled Tampons in Plastic Applicator is HEB.

Other records listing Albaad Fem 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.

K181911Interlude 100% Cotton TamponK173225Interlude and private label Unscented 3-piece compact applicator 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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