510(k) K012392

DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 by Pace Medical — Product Code DSA

K012392 is an FDA 510(k) premarket notification submitted by Pace Medical for the device "DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260". The FDA issued a decision of Substantially Equivalent on September 4, 2001. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Pace Medical has at least 10 other 510(k) clearances on record.