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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stent, colonic, metallic, expandable
510(k) Number K000281
FOIA Releasable 510(k) K000281
Device Name WALLSTENT ENTERNAL PROSTHESIS
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact LISA M QUAGLIA
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact LISA M QUAGLIA
Regulation Number878.3610
Classification Product Code
MQR  
Subsequent Product Code
MUM  
Date Received01/31/2000
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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