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FDA 510(k)

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

K-Number: K240708 · 2024-05-10

Decision Date2024-05-10
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Organic Cotton Tampon; Organic Cotton PESCVcord 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 2024-05-10 under 510(k) number K240708. 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 Organic Cotton Tampon; Organic Cotton PESCVcord Tampon?

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Suzhou Borage Medical Technology Co., Ltd.. The 510(k) number is K240708.

When did Organic Cotton Tampon; Organic Cotton PESCVcord Tampon receive FDA 510(k) clearance?

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240708.

Who is the listed applicant for Organic Cotton Tampon; Organic Cotton PESCVcord 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 Organic Cotton Tampon; Organic Cotton PESCVcord Tampon?

The FDA product code for Organic Cotton Tampon; Organic Cotton PESCVcord 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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