Name: Predicase
Price: 199 USD

K-number	K950178
Device name	PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
Applicant	Pharma-Plast Intl. A/S
Product code	LZE
Device class	Class I
Decision date	Jul 17, 1995
Decision	Substantially Equivalent
Regulation	888.1520

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Source

View the full FDA submission: accessdata.fda.gov

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PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET

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