Name: Predicase
Price: 199 USD

K-number	K925989
Device name	KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR
Applicant	Kendall Healthcare Products Co. Div.Of Tyco Health
Product code	GCY
Device class	Class I
Decision date	Feb 26, 1993
Decision	Substantially Equivalent
Regulation	878.4680

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Source

View the full FDA submission: accessdata.fda.gov

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KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR

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