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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K051068
Device Name ZUTRON COLONOSCOPE STIFFENING DEVICE
Applicant
Zutron Medical
9816 Pflumm Rd.
Lenexa,  KS  66215
Applicant Contact JORDAN HARTONG
Correspondent
Zutron Medical
9816 Pflumm Rd.
Lenexa,  KS  66215
Correspondent Contact JORDAN HARTONG
Regulation Number876.1500
Classification Product Code
FDF  
Date Received04/26/2005
Decision Date 07/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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