• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K091131
Device Name PELVIC FLOOR REPAIR SYSTEM
Applicant
BOSTONSCIENTIFIC
100 boston scientific way
marlborough,  MA  01752
Applicant Contact michelle berry
Correspondent
BOSTONSCIENTIFIC
100 boston scientific way
marlborough,  MA  01752
Correspodent Contact michelle berry
Regulation Number878.3300
Classification Product Code
OTP  
Date Received04/20/2009
Decision Date 05/08/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-