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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 pelvic organ prolapse, transvaginally placed
510(k) Number K092207
Device Name RESTORELLE POLYPROPYLENE MESH
Applicant
MPATHY MEDICAL DEVICES INC
208 WRIGHT BUSINESS CENTRE
LONMAY ROAD
GLASGOW,  GB G33-4EL
Applicant Contact CAROLINE STRETTON
Correspondent
MPATHY MEDICAL DEVICES INC
208 WRIGHT BUSINESS CENTRE
LONMAY ROAD
GLASGOW,  GB G33-4EL
Correspondent Contact CAROLINE STRETTON
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Code
OTO  
Date Received07/22/2009
Decision Date 08/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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