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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 apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K051245
Device Name POLYFORM SYNTHETIC MESH
Original Applicant
PROXY BIOMEDICAL LTD.
p.o. box 560
stillwater,  MN  55082
Original Contact elaine duncan
Regulation Number878.3300
Classification Product Code
OTO  
Date Received05/16/2005
Decision Date 06/17/2005
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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