510(k) K912344

MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS by Dacomed Corp. — Product Code FAE

K912344 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 11, 1991. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. Dacomed Corp. has at least 10 other 510(k) clearances on record.