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510(k) K053296

MENTOR ARIS SUPRAPUBIC SURGICAL KIT by Mentor Corporation — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
November 25, 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)
  • K052440 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (October 11, 2005)
  • K050148 — MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (March 9, 2005)

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