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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse
510(k) Number K173527
Device Name Digitex Delivery Device
Applicant
Coloplast A/S
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Nikita Basandra
Correspondent
Coloplast A/S
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Nikita Basandra
Regulation Number884.4910
Classification Product Code
PWI  
Date Received11/14/2017
Decision Date 02/12/2018
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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