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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 K090879
Device Name INSUFLOW CO2IONSHIELD
Applicant
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL,  MN  55110
Applicant Contact BERNARD HORWATH
Correspondent
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL,  MN  55110
Correspondent Contact BERNARD HORWATH
Regulation Number876.1500
Classification Product Code
FCX  
Date Received03/31/2009
Decision Date 07/23/2009
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
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