510(k) K800975

M.R. ASSOC. TRUE-FEEL HANDLE by Mr Associates, Inc. — Product Code KNS

K800975 is an FDA 510(k) premarket notification submitted by Mr Associates, Inc. for the device "M.R. ASSOC. TRUE-FEEL HANDLE". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Mr Associates, Inc. has at least 10 other 510(k) clearances on record.