Name: Predicase
Price: 199 USD

K-number	K971879
Device name	SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER
Applicant	Continuum Biomedical, Inc.
Product code	GEX
Device class	Class II
Decision date	Aug 14, 1997
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER

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