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510(k) K103022

KIM by Neomedic International S.L. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2011
Date Received
October 12, 2010
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 Neomedic International S.L.

  • K120831 — ANCHORSURE (October 12, 2012)

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