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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 pelvic organ prolapse, transvaginally placed
510(k) Number K130006
Device Name BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
Applicant
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Applicant Contact NICK X WANG
Correspondent
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Correspondent Contact NICK X WANG
Regulation Number884.5980
Classification Product Code
PAI  
Date Received01/02/2013
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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