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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K172040
Device Name Aquilex Fluid Control System AQL-100S
Applicant
W.O.M. World of Medicine GmbH
Salzufer 8
Berlin,  DE 10587
Applicant Contact Lucia Puetmann
Correspondent
Susanne Raab
Guenthersburgallee 75
Frankfurt,  DE 60389
Correspondent Contact Susanne Raab
Regulation Number884.1700
Classification Product Code
HIG  
Date Received07/05/2017
Decision Date 02/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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