Name: Predicase
Price: 199 USD

K-number	K994417
Device name	OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
Applicant	Cook Urological, Inc.
Product code	MQE
Device class	Class II
Decision date	Mar 1, 2000
Decision	Substantially Equivalent
Regulation	884.6100

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Source

View the full FDA submission: accessdata.fda.gov

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OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING

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