Name: Predicase
Price: 199 USD

K-number	K052111
Device name	XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
Applicant	Excel Tech. , Ltd.
Product code	GXZ
Device class	Class II
Decision date	Aug 17, 2005
Decision	Substantially Equivalent
Regulation	882.1350

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Source

View the full FDA submission: accessdata.fda.gov

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XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

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