Name: Predicase
Price: 199 USD

K-number	K855106
Device name	IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	JTT
Device class	Class II
Decision date	Mar 6, 1986
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645

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