510(k) K822848

PRIMARY & SECONDARY I.V. TUBING SETS by David Simmonds Co., Inc. — Product Code FPA

K822848 is an FDA 510(k) premarket notification submitted by David Simmonds Co., Inc. for the device "PRIMARY & SECONDARY I.V. TUBING SETS". The FDA issued a decision of Substantially Equivalent on October 15, 1982. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. David Simmonds Co., Inc. has at least 2 other 510(k) clearances on record.