K-number	K153128
Device name	Kolplast Cervical Sample Collection Kit
Applicant	Kolplast CI SA
Product code	HHT
Device class	Class II
Decision date	Jan 13, 2017
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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Kolplast Cervical Sample Collection Kit

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