FDA 510(k) Application Details - K092984

Device Classification Name Cannula, Manipulator/Injector, Uterine

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510(K) Number K092984
Device Name Cannula, Manipulator/Injector, Uterine
Applicant Panpac Medical Corporation
NO. 202, 6F-1.2, SEC.3
TATONG ROAD
SHI-CHIH CITY, TAIPEI HSIEN 22103 TW
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Contact Yen-Ming Pan
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Regulation Number 000.0000

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Classification Product Code LKF
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Date Received 09/28/2009
Decision Date 04/07/2010
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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