K-number	K832657
Device name	DISPOSABLE MANIFOLD SET
Applicant	Mallinckrodt Critical Care
Product code	DRS
Device class	Class II
Decision date	Nov 7, 1983
Decision	Substantially Equivalent
Regulation	870.2850

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View the full FDA submission: accessdata.fda.gov

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DISPOSABLE MANIFOLD SET

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