K-number	K212479
Device name	Cohitech Reusable Tampon Applicator
Applicant	Cotton High Tech S.L.
Product code	HEB
Device class	Class II
Decision date	Oct 8, 2021
Decision	Substantially Equivalent
Regulation	884.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Cohitech Reusable Tampon Applicator

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