510(k) K953640

DUNA II PENILE PROSTHESIS by Dacomed Corp. — Product Code FAE

K953640 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DUNA II PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 27, 1995. 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.