Name: Predicase
Price: 199 USD

K-number	K240708
Device name	Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
Applicant	Suzhou Borage Medical Technology Co., Ltd.
Product code	HEB
Device class	Class II
Decision date	May 10, 2024
Decision	Substantially Equivalent
Regulation	884.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

Everything you need for a 510(k) submission. Nothing you don't.