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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 K172929
Device Name Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Daniel FitzDaniel
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Daniel FitzDaniel
Classification Product Code
LJE  
Date Received09/25/2017
Decision Date 01/10/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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