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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 K952968
Device Name DILATATION CATHETER, BALLOON
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact Lorraine M Hanley
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact Lorraine M Hanley
Classification Product Code
LJE  
Subsequent Product Code
ENZ  
Date Received06/27/1995
Decision Date 08/10/1995
Decision Substantially Equivalent (SESE)
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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