Name: Predicase
Price: 199 USD

K-number	K110193
Device name	FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
Applicant	St. Jude Medical Systems AB
Product code	DXC
Device class	Class II
Decision date	Feb 24, 2011
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F

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