Name: Predicase
Price: 199 USD

K-number	K240523
Device name	VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
Applicant	Shenzhen Vitavitro Biotech Co., Ltd.
Product code	MQE
Device class	Class II
Decision date	Nov 15, 2024
Decision	Substantially Equivalent
Regulation	884.6100

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Source

View the full FDA submission: accessdata.fda.gov

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VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

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