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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K934697
Device Name MICROVASIVE MAXFORCE
Applicant
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472 -2407
Applicant Contact SHERI S O'BRIEN
Correspondent
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472 -2407
Correspondent Contact SHERI S O'BRIEN
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received09/30/1993
Decision Date 05/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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