510(k) K900371

MENTOR MODIFIED MALLEABLE PENILE PROSTHESES by Mentor Corp. — Product Code FAE

K900371 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR MODIFIED MALLEABLE PENILE PROSTHESES". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. Mentor Corp. has at least 10 other 510(k) clearances on record.