Name: Predicase
Price: 199 USD

K-number	K973044
Device name	DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
Applicant	Disetronic Medical Systems
Product code	LZG
Device class	Class II
Decision date	Sep 15, 1997
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP

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