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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 K020652
Original Applicant
8 orange dr.
jericho,  NY  11753
Original Contact lorena trabucco
Regulation Number878.3300
Classification Product Code
Date Received02/28/2002
Decision Date 05/15/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No