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FDA 510(k) Application Details - K190277
Device Classification Name
Pessary, Vaginal
More FDA Info for this Device
510(K) Number
K190277
Device Name
Pessary, Vaginal
Applicant
ConTIPI Medical Ltd.
2 Alon Ha'Tavor st. Caesarea Industrial Park, POB 3135
Caesarea 3088900 IL
Other 510(k) Applications for this Company
Contact
Tsvia Erlich
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
02/08/2019
Decision Date
07/08/2019
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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