The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Self-cath Hydrogel Intermittent Catheter.
| Device ID | K050008 |
| 510k Number | K050008 |
| Device Name: | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
| Classification | Catheter, Straight |
| Applicant | MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-03 |
| Decision Date | 2005-06-03 |
| Summary: | summary |