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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 K011467
Device Name ROSS EMBRACE PUMP SET
Applicant
Ross Products
625 Cleveland Ave.
Columbus,  OH  43215 -1724
Applicant Contact DANIEL HAMILTON
Correspondent
Ross Products
625 Cleveland Ave.
Columbus,  OH  43215 -1724
Correspondent Contact DANIEL HAMILTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/14/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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