510(k) K790670

PULSE GENERATOR MODEL 629 by Elema-Schonander, Inc. — Product Code DXY

K790670 is an FDA 510(k) premarket notification submitted by Elema-Schonander, Inc. for the device "PULSE GENERATOR MODEL 629". The FDA issued a decision of Substantially Equivalent on June 27, 1979. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Elema-Schonander, Inc. has at least 10 other 510(k) clearances on record.