510(k) K011336

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK by Churchill Medical Systems, Inc. — Product Code FPA

K011336 is an FDA 510(k) premarket notification submitted by Churchill Medical Systems, Inc. for the device "PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK". The FDA issued a decision of Substantially Equivalent on June 12, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Churchill Medical Systems, Inc. has at least 10 other 510(k) clearances on record.