510(k) K971290

STRATASYS FDM MEDMODELER SYSTEM by Paladin Medical, Inc. — Product Code LLZ

K971290 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "STRATASYS FDM MEDMODELER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 1997. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.