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 |