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FDA 510(k) Application Details - K173489
Device Classification Name
Insufflator, Hysteroscopic
More FDA Info for this Device
510(K) Number
K173489
Device Name
Insufflator, Hysteroscopic
Applicant
W.O.M. World of Medicine GmbH
Salzufer 8
Berlin 10587 DE
Other 510(k) Applications for this Company
Contact
Soeren Markworth
Other 510(k) Applications for this Contact
Regulation Number
884.1700
More FDA Info for this Regulation Number
Classification Product Code
HIG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2017
Decision Date
03/28/2018
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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