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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Nasogastric
510(k) Number K935688
Device Name AN-10S ANDERSEN TUBE WITH STYLET
Applicant
H.W. Andersen Products, Inc.
Box 1050
Chapel Hill,  NC  27514
Applicant Contact JUERGEN BALLO
Correspondent
H.W. Andersen Products, Inc.
Box 1050
Chapel Hill,  NC  27514
Correspondent Contact JUERGEN BALLO
Regulation Number876.5980
Classification Product Code
BSS  
Date Received11/29/1993
Decision Date 12/30/1994
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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