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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 K132181
Device Name GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
Applicant
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
136 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Applicant Contact NEIL KELLY
Correspondent
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
136 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Correspondent Contact NEIL KELLY
Regulation Number876.5470
Classification Product Code
EZN  
Subsequent Product Code
KOE  
Date Received07/15/2013
Decision Date 10/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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