Name: Predicase
Price: 199 USD

K-number	K024088
Device name	CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
Applicant	Biolitec, Inc.
Product code	GEX
Device class	Class II
Decision date	Jan 2, 2003
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25

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