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FDA 510(k) Application Details - K132670
Device Classification Name
Pessary, Vaginal
More FDA Info for this Device
510(K) Number
K132670
Device Name
Pessary, Vaginal
Applicant
Panpac Medical Corporation
NO. 202, 6F-1.2, SEC.3
TATONG ROAD
SHI-CHIH CITY, TAIPEI HSIEN 22103 TW
Other 510(k) Applications for this Company
Contact
Yen-Ming Pan
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
08/27/2013
Decision Date
06/04/2014
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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