Name: Predicase
Price: 199 USD

K-number	K080878
Device name	MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
Applicant	Medical Technologies of Georgia, Inc.
Product code	KOD
Device class	Class II
Decision date	Jul 17, 2008
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)

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