510(k) K834504

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

K834504 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "ESKA JONAS SILICON-SILVER PENILE". The FDA issued a decision of Substantially Equivalent on February 4, 1984. 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.