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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 a medical device manufactured by Albaad Fem. It received FDA 510(k) clearance on 2018-11-02 under approval 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. It is manufactured by Albaad Fem. The 510(k) number is K181911.

When was Interlude 100% Cotton Tampon approved by the FDA?

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

What company makes Interlude 100% Cotton Tampon?

Interlude 100% Cotton Tampon is manufactured by Albaad Fem.

What is the FDA product code for Interlude 100% Cotton Tampon?

The FDA product code for Interlude 100% Cotton Tampon is HEB.

Other Devices by Albaad Fem

K173225Interlude and private label Unscented 3-piece compact applicator tampon K191431Interlude Rolled Tampons in Plastic Applicator

Related Devices (Code: HEB)

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 K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem K180167Playtex Stella TamponsPlaytex Manufacturing, Inc.

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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