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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K940838
Device Name MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
Applicant
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Applicant Contact SHERI D O'BRIEN
Correspondent
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Correspondent Contact SHERI D O'BRIEN
Regulation Number878.3610
Classification Product Code
ESW  
Date Received02/23/1994
Decision Date 08/18/1994
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
Predetermined Change
Control Plan Authorized		 No
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