510(k) K780776

ARCOBIOLITH PACEMAKER MODEL by Arco Medical Products Co. — Product Code DXY

K780776 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "ARCOBIOLITH PACEMAKER MODEL". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.