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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, female, mini-sling
510(k) Number K110420
Device Name OPHIRA MINI SLING SYSTEM
Original Applicant
PROMEDON S.A.
221 ellis parkway
piscataway,  NJ  08854
Original Contact stephanie rais
Regulation Number878.3300
Classification Product Code
PAH  
Date Received02/17/2011
Decision Date 05/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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