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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K102712
Device Name MED GRAVITY SET, IMED PUMP SET
Applicant
Imed Technology, Inc.
17408 Tamaron Dr.
Dallas,  TX  75287
Applicant Contact BRANDON CONVERSE
Correspondent
Imed Technology, Inc.
17408 Tamaron Dr.
Dallas,  TX  75287
Correspondent Contact BRANDON CONVERSE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/20/2010
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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