Name: Predicase
Price: 199 USD

K-number	K151018
Device name	Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
Applicant	Cook Incorporated
Product code	MQH
Device class	Class II
Decision date	Jan 8, 2016
Decision	Substantially Equivalent
Regulation	884.6130

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Source

View the full FDA submission: accessdata.fda.gov

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Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

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