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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K180086
Device Name Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
Applicant
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact Mary Anne Patella
Correspondent
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact Mary Anne Patella
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received01/12/2018
Decision Date 03/08/2018
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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