510(k) K980141

SPECTRUM DESIGNS PROJECTION MALAR IMPLANT by Spectrum Designs, Inc. — Product Code LZK

K980141 is an FDA 510(k) premarket notification submitted by Spectrum Designs, Inc. for the device "SPECTRUM DESIGNS PROJECTION MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on March 3, 1998. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Spectrum Designs, Inc. has at least 10 other 510(k) clearances on record.