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FDA 510(k)

Interlude 100% Cotton Tampon

K-Number: K181911 · 2018-11-02

ApplicantAlbaad Fem
Decision Date2018-11-02
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Interlude 100% Cotton Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Albaad Fem. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K181911. 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 100% Cotton Tampon?

Interlude 100% Cotton Tampon is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Albaad Fem. The 510(k) number is K181911.

When did Interlude 100% Cotton Tampon receive FDA 510(k) clearance?

Interlude 100% Cotton Tampon received FDA 510(k) clearance on 2018-11-02, under 510(k) number K181911.

Who is the listed applicant for Interlude 100% Cotton Tampon?

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 100% Cotton Tampon?

The FDA product code for Interlude 100% Cotton Tampon 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.

K191431Interlude Rolled Tampons in Plastic ApplicatorK173225Interlude 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

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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