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510(k) K050148

MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT by Mentor Corporation — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2005
Date Received
January 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Other clearances by Mentor Corporation

  • K062421 — MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (October 10, 2006)
  • K053296 — MENTOR ARIS SUPRAPUBIC SURGICAL KIT (December 15, 2005)
  • K052440 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (October 11, 2005)

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