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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
Original Applicant
MENTOR CORP.
201 mentor drive
santa barbara,  CA  93111
Original Contact donna a crawford
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Codes
OTO   PAI   PAJ  
Date Received12/07/2005
Decision Date 12/27/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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