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FDA 510(k)

Callaly Tampliner

K-Number: K211469 · 2021-06-10

ApplicantCalla Lily Personal Care, Ltd.
Decision Date2021-06-10
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Callaly Tampliner is the device name listed in this FDA 510(k) record. The listed applicant is Calla Lily Personal Care, Ltd.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K211469. 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 Callaly Tampliner?

Callaly Tampliner is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Calla Lily Personal Care, Ltd.. The 510(k) number is K211469.

When did Callaly Tampliner receive FDA 510(k) clearance?

Callaly Tampliner received FDA 510(k) clearance on 2021-06-10, under 510(k) number K211469.

Who is the listed applicant for Callaly Tampliner?

The FDA 510(k) record lists Calla Lily Personal Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Callaly Tampliner?

The FDA product code for Callaly Tampliner is HEB.

Other records listing Calla Lily Personal Care, 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.

K212304Callaly Tampliner (super plus absorbency)K201003Callaly Tampliner

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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