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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 K011077
Device Name ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
Applicant
Andersen Products, Inc.
3202 Caroline Dr.
Health Science Park
Haw River,  NC  27258
Applicant Contact WENDY HEDRICK
Correspondent
Andersen Products, Inc.
3202 Caroline Dr.
Health Science Park
Haw River,  NC  27258
Correspondent Contact WENDY HEDRICK
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/09/2001
Decision Date 05/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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