The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Clear Advantage Ii.
| Device ID | K945628 |
| 510k Number | K945628 |
| Device Name: | CLEAR ADVANTAGE II |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Byron H Wicket |
| Correspondent | Byron H Wicket MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-16 |
| Decision Date | 1995-07-06 |