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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K953691
Device Name MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact STEPHEN B ANDERSON
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact STEPHEN B ANDERSON
Regulation Number876.5470
Classification Product Code
EZN  
Date Received08/08/1995
Decision Date 10/16/1995
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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