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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 K953597
Device Name NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
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  
Subsequent Product Codes
FGE   KOE   LJE  
Date Received08/01/1995
Decision Date 10/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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