510(k) K060897

EMBEDDING TOOL, MODEL TE-1000 by Medigroup, Inc. — Product Code FJS

K060897 is an FDA 510(k) premarket notification submitted by Medigroup, Inc. for the device "EMBEDDING TOOL, MODEL TE-1000". The FDA issued a decision of Substantially Equivalent on July 18, 2006. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Medigroup, Inc. has at least 10 other 510(k) clearances on record.