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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
510(k) Number K051533
Device Name I-STOP
Applicant
Cl Medical
28 Ave. General De Gaulle
Sainte Foy Les Lyon,  FR 69110
Applicant Contact VINCENT GORIA
Correspondent
Cl Medical
28 Ave. General De Gaulle
Sainte Foy Les Lyon,  FR 69110
Correspondent Contact VINCENT GORIA
Regulation Number878.3300
Classification Product Code
OTN  
Date Received06/09/2005
Decision Date 08/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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