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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bulb, Inflation, For Endoscope
510(k) Number K093718
Device Name ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
Applicant
Zutron Medical, LLC
9816 Pflumm Rd.
Lenexa,  KS  66215
Applicant Contact JORDAN HARTONG
Correspondent
Zutron Medical, LLC
9816 Pflumm Rd.
Lenexa,  KS  66215
Correspondent Contact JORDAN HARTONG
Regulation Number876.1500
Classification Product Code
FCY  
Date Received12/02/2009
Decision Date 02/22/2010
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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