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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, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K051190
Device Name XENFORM SOFT TISSUE REPAIR MATRIX
Original Applicant
TEI BIOSCIENCES INC.
7 elkins st.
boston,  MA  02127
Original Contact kenneth james
Regulation Number878.3300
Classification Product Code
PAJ  
Subsequent Product Codes
PAG   PAI  
Date Received05/13/2005
Decision Date 06/10/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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