Name: Predicase
Price: 199 USD

K-number	K050521
Device name	EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
Applicant	Inntec, Inc.
Product code	MQF
Device class	Class II
Decision date	May 2, 2005
Decision	Substantially Equivalent
Regulation	884.6110

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Source

View the full FDA submission: accessdata.fda.gov

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EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S

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