510(k) K910637

MENTOR(R) SUR-E-TROL(R) by Mentor O & O, Inc. — Product Code FRN

K910637 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MENTOR(R) SUR-E-TROL(R)". The FDA issued a decision of Substantially Equivalent on May 13, 1991. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.