510(k) K983630

SEARE BIOMEDICAL SILICONE RODS by Seare Biomedical Corp. — Product Code MIB

K983630 is an FDA 510(k) premarket notification submitted by Seare Biomedical Corp. for the device "SEARE BIOMEDICAL SILICONE RODS". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Seare Biomedical Corp. has at least 7 other 510(k) clearances on record.