510(k) K991388

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M by Pacific Andrology, Inc. — Product Code MQH

K991388 is an FDA 510(k) premarket notification submitted by Pacific Andrology, Inc. for the device "ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Pacific Andrology, Inc. has at least 1 other 510(k) clearance on record.