The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Cylinder Protector Tool (inflatable Penile).
Device ID | K890402 |
510k Number | K890402 |
Device Name: | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) |
Classification | Prosthesis, Penile |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Byron Wickett |
Correspondent | Byron Wickett 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 | 1989-01-24 |
Decision Date | 1989-08-03 |