Name: Predicase
Price: 199 USD

K-number	K190590
Device name	Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Applicant	Allwin Medical Devices, Inc.
Product code	MQE
Device class	Class II
Decision date	Nov 25, 2019
Decision	Substantially Equivalent
Regulation	884.6100

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Source

View the full FDA submission: accessdata.fda.gov

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Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

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