Name: Predicase
Price: 199 USD

K-number	K070988
Device name	SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
Applicant	Shinchang Medical Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Aug 23, 2007
Decision	Substantially Equivalent
Regulation	880.5570

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View the full FDA submission: accessdata.fda.gov

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SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)

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