Name: Predicase
Price: 199 USD

K-number	K222944
Device name	SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
Applicant	Safepath Medical, Inc.
Product code	GAP
Device class	Class II
Decision date	Oct 18, 2024
Decision	Substantially Equivalent
Regulation	878.5030

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Source

View the full FDA submission: accessdata.fda.gov

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SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

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