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FDA 510(k) Application Details - K032585
Device Classification Name
Tenaculum, Uterine
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HDC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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