Name: Predicase
Price: 199 USD

K-number	K171645
Device name	CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
Applicant	Strukmyer Medical
Product code	KGN
Device class	Class U
Decision date	Jul 25, 2017
Decision	Substantially Equivalent
Regulation	—

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

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