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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K101214
Device Name GUARDIAN CONNECTION
Applicant
Maulin Medical, LLC
486 E. Gentry Dr.
Pueblo West,  CO  81007
Applicant Contact SARA OWENS
Correspondent
Maulin Medical, LLC
486 E. Gentry Dr.
Pueblo West,  CO  81007
Correspondent Contact SARA OWENS
Regulation Number876.5980
Classification Product Code
FPD  
Date Received04/30/2010
Decision Date 07/23/2010
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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