K-number	K945193
Device name	ALL-IN-ONE TWO CHAMBER CONTAINER
Applicant	Baxter Healthcare Corp
Product code	KPE
Device class	Class II
Decision date	May 12, 1995
Decision	Substantially Equivalent
Regulation	880.5025

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Source

View the full FDA submission: accessdata.fda.gov

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ALL-IN-ONE TWO CHAMBER CONTAINER

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