510(k) K981260

KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M by Clinical Innovations, Inc. — Product Code HDB

K981260 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M". The FDA issued a decision of Substantially Equivalent on September 22, 1998. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Clinical Innovations, Inc. has at least 10 other 510(k) clearances on record.