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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 stress urinary incontinence, retropubic or transobturator
510(k) Number K992159
Device Name SURGISIS SLING
Original Applicant
COOK BIOTECH, INC.
3055 kent ave.
west lafayette,  IN  47906 1076
Original Contact neal e fearnot
Regulation Number878.3300
Classification Product Code
PAG  
Subsequent Product Codes
FTM   PAJ  
Date Received06/25/1999
Decision Date 09/23/1999
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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