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 K972054
Device Name INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
Applicant
Empi
599 Cardigan Rd.
St. Paul,  MN  55126
Applicant Contact CAROLYN M STEELE HUSTEN
Correspondent
Empi
599 Cardigan Rd.
St. Paul,  MN  55126
Correspondent Contact CAROLYN M STEELE HUSTEN
Regulation Number876.5320
Classification Product Code
KPI  
Date Received06/02/1997
Decision Date 08/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-