• 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
 


New Search Back To Search Results
Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
510(k) Number K053361
Device Name MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
Applicant
MPATHY MEDICAL DEVICES, LTD.
150 ARAN HILL ROAD
FAIRFIELD,  CT  06824 -1712
Applicant Contact LOUIS J MAZZARESE
Correspondent
MPATHY MEDICAL DEVICES, LTD.
150 ARAN HILL ROAD
FAIRFIELD,  CT  06824 -1712
Correspondent Contact LOUIS J MAZZARESE
Regulation Number878.3300
Classification Product Code
OTO  
Subsequent Product Code
OTP  
Date Received12/02/2005
Decision Date 02/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-