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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K031538
Device Name ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,,  MA  01760 -1537
Applicant Contact PAIGE SWEENEY
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,,  MA  01760 -1537
Correspondent Contact PAIGE SWEENEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/16/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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