The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Modified Malleable Penile Prostheses.
Device ID | K900371 |
510k Number | K900371 |
Device Name: | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES |
Classification | Prosthesis, Penile |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Terry A Thompson |
Correspondent | Terry A Thompson MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | FAE |
CFR Regulation Number | 876.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-26 |
Decision Date | 1990-11-02 |