The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Silicone Male External Catheter.
| Device ID | K913524 |
| 510k Number | K913524 |
| Device Name: | SILICONE MALE EXTERNAL CATHETER |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Byron H Wickett |
| Correspondent | Byron H Wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-08 |
| Decision Date | 1991-10-04 |