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

FDA 510(k)

NON APPLICATOR TAMPON, UNTREATED

K-Number: K954445 · 1996-02-12

ApplicantHygieia Healthcare , Ltd.
Decision Date1996-02-12
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NON APPLICATOR TAMPON, UNTREATED is the device name listed in this FDA 510(k) record. The listed applicant is Hygieia Healthcare , Ltd.. It received FDA 510(k) clearance on 1996-02-12 under 510(k) number K954445. 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 NON APPLICATOR TAMPON, UNTREATED?

NON APPLICATOR TAMPON, UNTREATED is a medical device that received FDA 510(k) clearance on 1996-02-12. The listed applicant is Hygieia Healthcare , Ltd.. The 510(k) number is K954445.

When did NON APPLICATOR TAMPON, UNTREATED receive FDA 510(k) clearance?

NON APPLICATOR TAMPON, UNTREATED received FDA 510(k) clearance on 1996-02-12, under 510(k) number K954445.

Who is the listed applicant for NON APPLICATOR TAMPON, UNTREATED?

The FDA 510(k) record lists Hygieia Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON APPLICATOR TAMPON, UNTREATED?

The FDA product code for NON APPLICATOR TAMPON, UNTREATED is HEB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hygieia Healthcare , Ltd. 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.

K950194TAMPON, UNTREATEDK912941TAMPON, UNTREATED

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.

↑