510(k) K895178

TECHNOMED PULSOLITH LASER SYSTEM by Teknomed, Inc. — Product Code FFK

K895178 is an FDA 510(k) premarket notification submitted by Teknomed, Inc. for the device "TECHNOMED PULSOLITH LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Teknomed, Inc. has at least 6 other 510(k) clearances on record.