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FDA 510(k)

VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS

K-Number: K983381 · 1998-10-19

ApplicantParagon Trade Brands, Inc.
Decision Date1998-10-19
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Trade Brands, Inc.. It received FDA 510(k) clearance on 1998-10-19 under 510(k) number K983381. 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 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS?

VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS is a medical device that received FDA 510(k) clearance on 1998-10-19. The listed applicant is Paragon Trade Brands, Inc.. The 510(k) number is K983381.

When did VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS receive FDA 510(k) clearance?

VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS received FDA 510(k) clearance on 1998-10-19, under 510(k) number K983381.

Who is the listed applicant for VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS?

The FDA 510(k) record lists Paragon Trade Brands, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS?

The FDA product code for VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS is HEB.

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Other records listing Paragon Trade Brands, Inc. 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.

K981953VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELSK962962DEODORANT PANTY LINERK962953DEODORANT PANTY SHIELDK962954DEODORANT MAXI PADK953333MENSTRUAL TAMPONK953668UNSCENTED ULTRATHIN MAXI PAD

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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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