Name: Predicase
Price: 199 USD

K-number	K000442
Device name	ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
Applicant	Medical Concepts Development, Inc.
Product code	KKX
Device class	Class II
Decision date	Apr 24, 2001
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

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