510(k) K062320

SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 by Cook Biotech, Inc. — Product Code FTM

K062320 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100". The FDA issued a decision of Substantially Equivalent on October 2, 2006. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.