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 Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K012785
Device Name TWINTRODE ELC 134 ELECTRODE
Applicant
Healthtronics Surgical Services, Inc.
1841 W. Oak Pkwy.
Suite A
Marietta,  GA  30062
Applicant Contact PETER WEIMAN
Correspondent
Healthtronics Surgical Services, Inc.
1841 W. Oak Pkwy.
Suite A
Marietta,  GA  30062
Correspondent Contact PETER WEIMAN
Regulation Number876.5990
Classification Product Code
LNS  
Date Received08/20/2001
Decision Date 11/16/2001
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
-
-