FDA 510(k) Application Details - K992071

Device Classification Name Tenaculum, Uterine

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510(K) Number K992071
Device Name Tenaculum, Uterine
Applicant RON-TECH MEDICAL LTD.
P.O. BOX 454
GINOT SHOMRON 44853 IL
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Contact AHAVA STEIN
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Regulation Number 884.4530

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Classification Product Code HDC
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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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