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FDA 510(k) Application Details - K992071
Device Classification Name
Tenaculum, Uterine
More FDA Info for this Device
510(K) Number
K992071
Device Name
Tenaculum, Uterine
Applicant
RON-TECH MEDICAL LTD.
P.O. BOX 454
GINOT SHOMRON 44853 IL
Other 510(k) Applications for this Company
Contact
AHAVA STEIN
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
06/18/1999
Decision Date
08/27/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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