510(k) K982688

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK by Spectrum Designs, Inc. — Product Code MIB

K982688 is an FDA 510(k) premarket notification submitted by Spectrum Designs, Inc. for the device "SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK". The FDA issued a decision of Substantially Equivalent on October 13, 1998. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Spectrum Designs, Inc. has at least 10 other 510(k) clearances on record.