510(k) K864405

MANAN CONTRAST MEDIA ADMINISTRATION SET by Manan Manufacturing Co., Inc. — Product Code FPA

K864405 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "MANAN CONTRAST MEDIA ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on December 18, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.