Name: Predicase
Price: 199 USD

K-number	K221110
Device name	LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
Applicant	Huizhou Foryou Medical Devices Co., Ltd.
Product code	FRO
Device class	Class U
Decision date	Jan 4, 2024
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing

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