Name: Predicase
Price: 199 USD

K-number	K053208
Device name	CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
Applicant	Swemed Lab International AB
Product code	MQF
Device class	Class II
Decision date	Jan 30, 2006
Decision	Substantially Equivalent
Regulation	884.6110

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Source

View the full FDA submission: accessdata.fda.gov

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CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET

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