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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K201096
Device Name CO2mbiLED
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact Winkie Wong
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact Winkie Wong
Regulation Number876.1500
Classification Product Code
FCX  
Subsequent Product Codes
FEQ   NTN  
Date Received04/24/2020
Decision Date 06/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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