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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 K201355
Device Name Endomat Select, IBS Shaver Software, License
Applicant
Karl Storz SE & Co. KG
Dr.-Karl-Storz-Strasse 34
Tuttlingen,  DE 78532
Applicant Contact Alexey Davidov
Correspondent
Karl Storz SE & Co. KG
Dr.-Karl-Storz-Strasse 34
Tuttlingen,  DE 78532
Correspondent Contact Alexey Davidov
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Codes
BTA   EOB   GWG   HRX   LJH  
OCX  
Date Received05/21/2020
Decision Date 07/22/2020
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
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