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FDA 510(k) Application Details - K161106
Device Classification Name
Cannula, Suction, Uterine
More FDA Info for this Device
510(K) Number
K161106
Device Name
Cannula, Suction, Uterine
Applicant
PANPAC MEDICAL CORPORATION
6F-1,2, NO. 202, SEC.3, TA-TONG ROAD
SHI-CHIH DIST. 22103 TW
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Contact
YEN-MING PAN
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Regulation Number
884.5070
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Classification Product Code
HGH
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More FDA Info for this Product Code
Date Received
04/19/2016
Decision Date
01/13/2017
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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