510(k) K952664

SOLUTION ADMINISTRATION SET by Distronic Sterile Products, Inc. — Product Code FPA

K952664 is an FDA 510(k) premarket notification submitted by Distronic Sterile Products, Inc. for the device "SOLUTION ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on August 7, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Distronic Sterile Products, Inc. has at least 7 other 510(k) clearances on record.