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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
Applicant
PROXY BIOMEDICAL LTD.
P.O. BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
PROXY BIOMEDICAL LTD.
P.O. BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number878.3300
Classification Product Code
OTO  
Date Received05/16/2005
Decision Date 06/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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