510(k) K092554

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES by Sunlight Medical, Inc. — Product Code MQH

K092554 is an FDA 510(k) premarket notification submitted by Sunlight Medical, Inc. for the device "BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES". The FDA issued a decision of Substantially Equivalent on April 30, 2010. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Sunlight Medical, Inc. has at least 1 other 510(k) clearance on record.