510(k) K820081

ESKA JONAS SILICONE-SILVER PENILE PROST by Dacomed Corp. — Product Code FAE

K820081 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "ESKA JONAS SILICONE-SILVER PENILE PROST". The FDA issued a decision of Substantially Equivalent on January 25, 1982. 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.