510(k) K072600

INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES by Sunlight Medical, Inc. — Product Code MQH

K072600 is an FDA 510(k) premarket notification submitted by Sunlight Medical, Inc. for the device "INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES". The FDA issued a decision of Substantially Equivalent on May 19, 2008. 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.