Name: Predicase
Price: 199 USD

K-number	K032636
Device name	PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
Applicant	Playtex Products, Inc.
Product code	HEB
Device class	Class II
Decision date	Nov 14, 2003
Decision	Substantially Equivalent
Regulation	884.5470

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Source

View the full FDA submission: accessdata.fda.gov

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PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)

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