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 Tenaculum, Uterine
510(k) Number K032585
Device Name TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
Applicant
Ron-Tech Medical , Ltd.
26 Hasivim St.
Kiryat Matalon
Petach-Tikva,  IL 49170
Applicant Contact DORON KILCHEVSKY
Correspondent
Ron-Tech Medical , Ltd.
26 Hasivim St.
Kiryat Matalon
Petach-Tikva,  IL 49170
Correspondent Contact DORON KILCHEVSKY
Regulation Number884.4530
Classification Product Code
HDC  
Subsequent Product Code
ITX  
Date Received08/21/2003
Decision Date 01/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-