MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

MENTOR CORPORATION

The following data is part of a premarket notification filed by Mentor Corporation with the FDA for Mentor Aris Trans-obturator Tape And Surgical Kit.

Pre-market Notification Details

• Device ID: K050148
• 510k Number: K050148
• Device Name: MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
• Classification: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
• Applicant: MENTOR CORPORATION 201 MENTOR DRIVE Santa Barbara, CA 93111
• Contact: Donna Crawford
• Correspondent: Donna Crawford; MENTOR CORPORATION 201 MENTOR DRIVE Santa Barbara, CA 93111
• Product Code: OTN
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-24
• Decision Date: 2005-03-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05708932442961	K050148	000