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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
Applicant
PROMEDON S.A.
221 ellis parkway
piscataway,  NJ  08854
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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