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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K944143
Device Name MS CLASSIQUE BALLOON CATHETER
Applicant
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact STEPHEN B ANDERSON
Correspondent
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact STEPHEN B ANDERSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/25/1994
Decision Date 03/13/1995
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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