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FDA 510(k)

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

K-Number: K182813 · 2019-03-15

ApplicantCotton High Tech S.L.
Decision Date2019-03-15
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT is a medical device manufactured by Cotton High Tech S.L.. It received FDA 510(k) clearance on 2019-03-15 under approval number K182813. 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 APPLICATOR TAMPONS LIGHT?

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Cotton High Tech S.L.. The 510(k) number is K182813.

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

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT received FDA 510(k) clearance on 2019-03-15, under approval number K182813.

What company makes COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT?

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

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

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

Other Devices by Cotton High Tech S.L.

K211775Cohitech Organic Cotton Non-Applicator Cottonlock Tampons K212479Cohitech Reusable Tampon Applicator K220238Cohitech Cottonlock Tampons with Reusable Applicator K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

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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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