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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 K053414
Device Name MENTOR NOVASILK MESH
Applicant
MENTOR CORP.
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
MENTOR CORP.
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Codes
OTO   PAI   PAJ  
Date Received12/07/2005
Decision Date 12/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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