Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K070331
Device Name UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
Applicant
LABORIE MEDICAL TECHNOLOGIES
400 AVENUE D SUITE 10
WILLISTON,  VT  05495
Applicant Contact BARBARA MORNET
Correspondent
LABORIE MEDICAL TECHNOLOGIES
400 AVENUE D SUITE 10
WILLISTON,  VT  05495
Correspondent Contact BARBARA MORNET
Regulation Number876.5320
Classification Product Code
KPI  
Date Received02/05/2007
Decision Date 05/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-