Name: Predicase
Price: 199 USD

K-number	K070287
Device name	PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
Applicant	Photonic Optische Gerate GmbH & Cokg
Product code	EBA
Device class	Class I
Decision date	Feb 12, 2007
Decision	Substantially Equivalent
Regulation	872.4630

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Source

View the full FDA submission: accessdata.fda.gov

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PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500

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