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FDA 510(k)

Unscented Menstrual Tampon

K-Number: K222046 · 2022-09-30

Decision Date2022-09-30
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unscented Menstrual Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Borage Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K222046. 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 Unscented Menstrual Tampon?

Unscented Menstrual Tampon is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Suzhou Borage Medical Technology Co., Ltd.. The 510(k) number is K222046.

When did Unscented Menstrual Tampon receive FDA 510(k) clearance?

Unscented Menstrual Tampon received FDA 510(k) clearance on 2022-09-30, under 510(k) number K222046.

Who is the listed applicant for Unscented Menstrual Tampon?

The FDA 510(k) record lists Suzhou Borage Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unscented Menstrual Tampon?

The FDA product code for Unscented Menstrual Tampon is HEB.

Other records listing Suzhou Borage Medical Technology Co., 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.

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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