The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Self-cath Plus.
| Device ID | K003784 |
| 510k Number | K003784 |
| Device Name: | MENTOR SELF-CATH PLUS |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-07 |
| Decision Date | 2001-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932277235 | K003784 | 000 |
| 05708932279857 | K003784 | 000 |
| 05708932277297 | K003784 | 000 |
| 05708932279772 | K003784 | 000 |
| 05708932277310 | K003784 | 000 |
| 05708932277266 | K003784 | 000 |
| 05708932279765 | K003784 | 000 |
| 05708932279741 | K003784 | 000 |
| 05708932277198 | K003784 | 000 |
| 05708932277167 | K003784 | 000 |
| 05708932277327 | K003784 | 000 |
| 05708932279963 | K003784 | 000 |
| 05708932279727 | K003784 | 000 |
| 05708932279697 | K003784 | 000 |
| 05708932277242 | K003784 | 000 |
| 05708932279802 | K003784 | 000 |
| 05708932279826 | K003784 | 000 |
| 05708932279918 | K003784 | 000 |
| 05708932279987 | K003784 | 000 |
| 05708932277150 | K003784 | 000 |
| 05708932279833 | K003784 | 000 |
| 05708932279888 | K003784 | 000 |
| 05708932279895 | K003784 | 000 |
| 05708932279932 | K003784 | 000 |
| 05708932277204 | K003784 | 000 |