510(k) K962144

PHOENIX ETE TISSUE EXTENSION SYSTEM by Phoenix Biomedical Corp. — Product Code MKY

K962144 is an FDA 510(k) premarket notification submitted by Phoenix Biomedical Corp. for the device "PHOENIX ETE TISSUE EXTENSION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 1997. The device falls under product code MKY (System, Skin Closure), a Class I device regulated under 21 CFR 878.4320. Phoenix Biomedical Corp. has at least 10 other 510(k) clearances on record.