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 |