510(k) K841326

REPLACE-A-TIP RECHARGEABLE HIGH TEMP by Suncoast Medical Manufacturers, Inc. — Product Code HQP

K841326 is an FDA 510(k) premarket notification submitted by Suncoast Medical Manufacturers, Inc. for the device "REPLACE-A-TIP RECHARGEABLE HIGH TEMP". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Suncoast Medical Manufacturers, Inc. has at least 10 other 510(k) clearances on record.