Name: Predicase
Price: 199 USD

K-number	K131161
Device name	EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
Applicant	CIVCO Medical Instruments Co., Inc.
Product code	ITX
Device class	Class II
Decision date	Sep 17, 2013
Decision	Substantially Equivalent
Regulation	892.1570

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Source

View the full FDA submission: accessdata.fda.gov

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EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,

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