Name: Predicase
Price: 199 USD

K-number	K142646
Device name	XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
Applicant	Genadyne Biotechnologies, Inc.
Product code	OMP
Device class	Class II
Decision date	Apr 30, 2015
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and

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