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FDA 510(k)

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

K-Number: K252939 · 2025-10-09

ApplicantCotton High Tech S.L.
Decision Date2025-10-09
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is a medical device manufactured by Cotton High Tech S.L.. It received FDA 510(k) clearance on 2025-10-09 under approval number K252939. 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 COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is a medical device that received FDA 510(k) clearance on 2025-10-09. It is manufactured by Cotton High Tech S.L.. The 510(k) number is K252939.

When was COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS approved by the FDA?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS received FDA 510(k) clearance on 2025-10-09, under approval number K252939.

What company makes COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is manufactured by Cotton High Tech S.L..

What is the FDA product code for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

The FDA product code for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is HEB.

Other Devices by Cotton High Tech S.L.

K182813COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT K211775Cohitech Organic Cotton Non-Applicator Cottonlock Tampons K212479Cohitech Reusable Tampon Applicator K220238Cohitech Cottonlock Tampons with Reusable 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 K181911Interlude 100% Cotton TamponAlbaad Fem K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem

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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