510(k) K051045

SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 by Spectrx, Inc. — Product Code FRN

K051045 is an FDA 510(k) premarket notification submitted by Spectrx, Inc. for the device "SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30". The FDA issued a decision of Substantially Equivalent on August 2, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Spectrx, Inc. has at least 1 other 510(k) clearance on record.