• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Original Applicant
COOK BIOTECH INCORPORATED
1425 innovation place
west lafayette,  IN  47906
Original Contact nick x wang
Regulation Number878.3300
Classification Product Code
PAI  
Date Received01/08/2013
Decision Date 04/05/2013
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
-
-