Name: Predicase
Price: 199 USD

K-number	K231734
Device name	STERiJECT Low Dead Space, STERiJECT The Invisible Needle
Applicant	Tsk Laboratory International Japan KK
Product code	QNS
Device class	Class II
Decision date	Mar 8, 2024
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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STERiJECT Low Dead Space, STERiJECT The Invisible Needle

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