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510(k) K062341

MALE REMEEX SYSTEM by Specialities Remeex International, S.L. — Product Code OTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2006
Date Received
August 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

surgical treatment of male stress urinary incontinence post-prostatectomy

Other clearances by Specialities Remeex International, S.L.

  • K063136 — NEEDLELESS SLING (December 19, 2006)
  • K033310 — REMEEX SYSTEM FOR URINARY INCONTINENCE (January 15, 2004)

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