Name: Predicase
Price: 199 USD

K-number	K040636
Device name	CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
Applicant	Smiths Medical MD, Inc.
Product code	FPA
Device class	Class II
Decision date	May 19, 2004
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET

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