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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
Applicant Contact STEPHANIE RAIS
Correspondent
PROMEDON S.A.
221 ELLIS PARKWAY
PISCATAWAY,  NJ  08854
Correspondent Contact STEPHANIE RAIS
Regulation Number878.3300
Classification Product Code
PAH  
Date Received02/14/2011
Decision Date 05/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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