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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 K023898
Device Name GYNE IDEAS MINITAPE RP DEVICE
Original Applicant
GYNE IDEAS LTD.
150 aran hill rd.
fairfield,  CT  06824
Original Contact louis mazzarese
Regulation Number878.3300
Classification Product Code
PAH  
Date Received11/22/2002
Decision Date 06/18/2003
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
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