Name: Predicase
Price: 199 USD

K-number	K101575
Device name	APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
Applicant	Omnlife Science
Product code	LPH
Device class	Class II
Decision date	Jun 30, 2010
Decision	Substantially Equivalent
Regulation	888.3358

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Source

View the full FDA submission: accessdata.fda.gov

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APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010

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