510(k) K830917

SURGITEK SIZER FOR PENILE PROSTHESIS by Medical Engineering Corp. — Product Code FAE

K830917 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK SIZER FOR PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.