The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Obtape Trans-obturator Surgical Kit.
Device ID | K042851 |
510k Number | K042851 |
Device Name: | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT |
Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
Applicant | MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
Contact | Donna Crawford |
Correspondent | Donna Crawford MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
Product Code | OTN |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-15 |
Decision Date | 2004-11-09 |
Summary: | summary |