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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, retention type, balloon
510(k) Number K082919
Device Name UC-CARE POSITIONING SYSTEM
Applicant
UC-CARE MEDICAL SYSTEMS LTD
555 13TH ST., NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
UC-CARE MEDICAL SYSTEMS LTD
555 13TH ST., NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/30/2008
Decision Date 10/27/2008
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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