510(k) K895604

SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES by Medical Design & Manufacturing Corp. — Product Code GXY

K895604 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.