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FDA 510(k) Application Details - K132313
Device Classification Name
Pessary, Vaginal
More FDA Info for this Device
510(K) Number
K132313
Device Name
Pessary, Vaginal
Applicant
EIS CORPORATION
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul 135-768 KR
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Contact
YANG HO DONG
Other 510(k) Applications for this Contact
Regulation Number
884.3575
More FDA Info for this Regulation Number
Classification Product Code
HHW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/25/2013
Decision Date
12/05/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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