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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K062240
Device Name CAREVENT
Applicant
Chief Medical, LLC
P.O. Box 772
105 Pioneer Lane
Teton Village,  WY  83025
Applicant Contact SCOTT HORN
Correspondent
Chief Medical, LLC
P.O. Box 772
105 Pioneer Lane
Teton Village,  WY  83025
Correspondent Contact SCOTT HORN
Regulation Number876.5130
Classification Product Code
KNY  
Date Received08/02/2006
Decision Date 10/16/2006
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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