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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, nephrostomy
510(k) Number K952887
Device Name NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION 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
Classification Product Code
LJE  
Date Received06/23/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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