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FDA 510(k)

Cohitech Cottonlock Tampons with Reusable Applicator

K-Number: K220238 · 2022-02-25

Decision Date2022-02-25
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cohitech Cottonlock Tampons with Reusable 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 2022-02-25 under 510(k) number K220238. 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 Cottonlock Tampons with Reusable Applicator?

Cohitech Cottonlock Tampons with Reusable Applicator is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K220238.

When did Cohitech Cottonlock Tampons with Reusable Applicator receive FDA 510(k) clearance?

Cohitech Cottonlock Tampons with Reusable Applicator received FDA 510(k) clearance on 2022-02-25, under 510(k) number K220238.

Who is the listed applicant for Cohitech Cottonlock Tampons with Reusable 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 Cottonlock Tampons with Reusable Applicator?

The FDA product code for Cohitech Cottonlock Tampons with Reusable 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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