510(k) K983794

CHEMO MINI SPIKE PLUS by B. Braun of America, Inc. — Product Code LHI

K983794 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "CHEMO MINI SPIKE PLUS". The FDA issued a decision of Substantially Equivalent on March 23, 1999. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.