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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 K010797
Device Name RUSCH MILLER-ABBOTT TUBE
Applicant
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Applicant Contact JULIE A BEAUMONT
Correspondent
RUSCH INTL.
50 PLANTATION DR.
JAFFERY,  NH  03452
Correspondent Contact JULIE A BEAUMONT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/16/2001
Decision Date 02/26/2002
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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