Name: Predicase
Price: 199 USD

K-number	K231404
Device name	T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
Applicant	Healthium Medtech Limited
Product code	MBI
Device class	Class II
Decision date	Aug 4, 2023
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

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