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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, transabdominal repair of pelvic organ prolapse
510(k) Number K173501
Device Name Meridian Vaginal Positioning System (VPS)
Applicant
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Diane Brinza
Correspondent
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Diane Brinza
Regulation Number884.4910
Classification Product Code
PWK  
Subsequent Product Code
LKF  
Date Received11/13/2017
Decision Date 02/09/2018
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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