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FDA 510(k)

Callaly Tampliner (super plus absorbency)

K-Number: K212304 · 2021-08-19

ApplicantCalla Lily Personal Care, Ltd.
Decision Date2021-08-19
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Callaly Tampliner (super plus absorbency) 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 2021-08-19 under 510(k) number K212304. 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 (super plus absorbency)?

Callaly Tampliner (super plus absorbency) is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Calla Lily Personal Care, Ltd.. The 510(k) number is K212304.

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

Callaly Tampliner (super plus absorbency) received FDA 510(k) clearance on 2021-08-19, under 510(k) number K212304.

Who is the listed applicant for Callaly Tampliner (super plus absorbency)?

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 (super plus absorbency)?

The FDA product code for Callaly Tampliner (super plus absorbency) 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.

K211469Callaly TamplinerK201003Callaly 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.

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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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