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FDA 510(k)

HARMONIES MENSTRUAL TAMPON

K-Number: K970108 · 1997-04-03

ApplicantEcoprogress Intl.
Decision Date1997-04-03
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HARMONIES MENSTRUAL TAMPON is the device name listed in this FDA 510(k) record. The listed applicant is Ecoprogress Intl.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K970108. 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 HARMONIES MENSTRUAL TAMPON?

HARMONIES MENSTRUAL TAMPON is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Ecoprogress Intl.. The 510(k) number is K970108.

When did HARMONIES MENSTRUAL TAMPON receive FDA 510(k) clearance?

HARMONIES MENSTRUAL TAMPON received FDA 510(k) clearance on 1997-04-03, under 510(k) number K970108.

Who is the listed applicant for HARMONIES MENSTRUAL TAMPON?

The FDA 510(k) record lists Ecoprogress Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARMONIES MENSTRUAL TAMPON?

The FDA product code for HARMONIES MENSTRUAL TAMPON is HEB.

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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.

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