Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tosama Biobased Applicator Tube Menstrual Tampon

K-Number: K172504 · 2018-02-09

ApplicantTosama, D.O.O.
Decision Date2018-02-09
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Tosama Biobased Applicator Tube Menstrual Tampon is a medical device manufactured by Tosama, D.O.O.. It received FDA 510(k) clearance on 2018-02-09 under approval number K172504. 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 Tosama Biobased Applicator Tube Menstrual Tampon?

Tosama Biobased Applicator Tube Menstrual Tampon is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Tosama, D.O.O.. The 510(k) number is K172504.

When was Tosama Biobased Applicator Tube Menstrual Tampon approved by the FDA?

Tosama Biobased Applicator Tube Menstrual Tampon received FDA 510(k) clearance on 2018-02-09, under approval number K172504.

What company makes Tosama Biobased Applicator Tube Menstrual Tampon?

Tosama Biobased Applicator Tube Menstrual Tampon is manufactured by Tosama, D.O.O..

What is the FDA product code for Tosama Biobased Applicator Tube Menstrual Tampon?

The FDA product code for Tosama Biobased Applicator Tube Menstrual Tampon is HEB.

Related Clinical Trials

NCT07561905 Tampon Safety-in-Use Study RECRUITING

Other Devices by Tosama, D.O.O.

K232060TOSAMA 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.

↑