Name: Predicase
Price: 199 USD

K-number	K231363
Device name	Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Applicant	Hantech Medical Device Co., Ltd.
Product code	NGT
Device class	Class II
Decision date	Sep 27, 2023
Decision	Substantially Equivalent
Regulation	880.5200

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Source

View the full FDA submission: accessdata.fda.gov

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Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

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