• 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 stress urinary incontinence, retropubic or transobturator
510(k) Number K974098
Device Name PUBOUURETHRAL SLING
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
somerville,  NJ  08876 -0151
Applicant Contact gregory r jones
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
somerville,  NJ  08876 -0151
Correspondent Contact gregory r jones
Regulation Number878.3300
Classification Product Code
OTN  
Date Received10/30/1997
Decision Date 01/28/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-