Name: Predicase
Price: 199 USD

K-number	K010716
Device name	VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
Applicant	Valmed Corp.
Product code	FSY
Device class	Class II
Decision date	May 30, 2001
Decision	Substantially Equivalent
Regulation	878.4580

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Source

View the full FDA submission: accessdata.fda.gov

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VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB

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