Name: Predicase
Price: 199 USD

K-number	K061089
Device name	MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
Applicant	Biopro, Inc.
Product code	KYI
Device class	Class II
Decision date	Jun 20, 2006
Decision	Substantially Equivalent
Regulation	888.3770

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Source

View the full FDA submission: accessdata.fda.gov

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MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599

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