510(k) K991381

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA by Pacific Andrology, Inc. — Product Code MQL

K991381 is an FDA 510(k) premarket notification submitted by Pacific Andrology, Inc. for the device "PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA". The FDA issued a decision of Substantially Equivalent on September 24, 1999. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Pacific Andrology, Inc. has at least 1 other 510(k) clearance on record.