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FDA 510(k) Application Details - K173351
Device Classification Name
Pessary, Vaginal
More FDA Info for this Device
510(K) Number
K173351
Device Name
Pessary, Vaginal
Applicant
Panpac Medical Corporation
6F-1,-2, No. 202, Sec. 3,
Ta-Tong Rd.
Shi-Chih Dist. 22103 TW
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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
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More FDA Info for this Product Code
Date Received
10/25/2017
Decision Date
10/31/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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