510(k) K982065

STERILE SILICONE EXTERNAL WOUND COVER by Specialty Surgical Products, Inc. — Product Code MIB

K982065 is an FDA 510(k) premarket notification submitted by Specialty Surgical Products, Inc. for the device "STERILE SILICONE EXTERNAL WOUND COVER". The FDA issued a decision of Substantially Equivalent on August 12, 1998. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Specialty Surgical Products, Inc. has at least 10 other 510(k) clearances on record.