Name: Predicase
Price: 199 USD

K-number	K092337
Device name	PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
Applicant	Baylis Medical Co., Inc.
Product code	GXI
Device class	Class II
Decision date	Oct 16, 2009
Decision	Substantially Equivalent
Regulation	882.4725

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Source

View the full FDA submission: accessdata.fda.gov

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PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS

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