• 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 apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K051245
Device Name POLYFORM SYNTHETIC MESH
Applicant
PROXY BIOMEDICAL LTD.
p.o. box 560
stillwater,  MN  55082
Applicant Contact elaine duncan
Correspondent
PROXY BIOMEDICAL LTD.
p.o. box 560
stillwater,  MN  55082
Correspodent Contact elaine duncan
Regulation Number878.3300
Classification Product Code
OTO  
Date Received05/16/2005
Decision Date 06/17/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-