Name: Predicase
Price: 199 USD

K-number	K191015
Device name	Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
Applicant	Cook Incorporated
Product code	MQF
Device class	Class II
Decision date	May 17, 2019
Decision	Substantially Equivalent
Regulation	884.6110

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Source

View the full FDA submission: accessdata.fda.gov

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Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)

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