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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 K180735
Device Name Endomat Select
Applicant
Karl Storz SE & Co. KG
Dr.-Karl-Storz-StraBe 34
Tuttlingen,  DE 78532
Applicant Contact Serkan Sezer
Correspondent
Karl Storz SE & Co. KG
Dr.-Karl-Storz-StraBe 34
Tuttlingen,  DE 78532
Correspondent Contact Nina Dusper
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Codes
BTA   GWG   HRX   LJH   OCX  
Date Received03/22/2018
Decision Date 10/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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