510(k) K041562

CRYOTIP by Irvine Scientific Sales Co., Inc. — Product Code MQH

K041562 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "CRYOTIP". The FDA issued a decision of Substantially Equivalent on August 9, 2004. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Irvine Scientific Sales Co., Inc. has at least 10 other 510(k) clearances on record.