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FDA 510(k) Application Details - K173070
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K173070
Device Name
Hysteroscope (And Accessories)
Applicant
Henke-Sass, Wolf GmbH
Keltenstrasse 1
Tuttlingen 78532 DE
Other 510(k) Applications for this Company
Contact
Anna Reifschneider
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2017
Decision Date
06/08/2018
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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