Name: Predicase
Price: 199 USD

K-number	K232165
Device name	Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
Applicant	Berpu Medical Technology Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Feb 1, 2024
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles

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