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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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