Name: Predicase
Price: 199 USD

K-number	K063568
Device name	HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
Applicant	Suzhou Medical Appliance Factory
Product code	ILY
Device class	Class II
Decision date	Mar 22, 2007
Decision	Substantially Equivalent
Regulation	890.5500

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Source

View the full FDA submission: accessdata.fda.gov

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HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL

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