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510(k) K033310

REMEEX SYSTEM FOR URINARY INCONTINENCE by Specialities Remeex International, S.L. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2004
Date Received
October 14, 2003
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 Specialities Remeex International, S.L.

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  • K062341 — MALE REMEEX SYSTEM (November 2, 2006)

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