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FDA 510(k)

Cohitech Reusable Tampon Applicator

K-Number: K212479 · 2021-10-08

Decision Date2021-10-08
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cohitech Reusable Tampon Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Cotton High Tech S.L.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K212479. 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 Cohitech Reusable Tampon Applicator?

Cohitech Reusable Tampon Applicator is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K212479.

When did Cohitech Reusable Tampon Applicator receive FDA 510(k) clearance?

Cohitech Reusable Tampon Applicator received FDA 510(k) clearance on 2021-10-08, under 510(k) number K212479.

Who is the listed applicant for Cohitech Reusable Tampon Applicator?

The FDA 510(k) record lists Cotton High Tech S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cohitech Reusable Tampon Applicator?

The FDA product code for Cohitech Reusable Tampon Applicator is HEB.

Other records listing Cotton High Tech S.L. 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.

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.