FDA 510(k) Application Details - K032585

Device Classification Name Tenaculum, Uterine

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510(K) Number K032585
Device Name Tenaculum, Uterine
Applicant RON-TECH MEDICAL LTD.
26 HASIVIM ST.
KIRYAT MATALON
PETACH-TIKVA 49170 IL
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Contact DORON KILCHEVSKY
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Regulation Number 884.4530

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Classification Product Code HDC
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Date Received 08/21/2003
Decision Date 01/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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