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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 K002363
Device Name MEDOVATIONS ESOPHAGEAL DILATOR
Applicant
Medovations, Inc.
1294 Barclay Blvd.
Buffalo Grove,  IL  60089
Applicant Contact MICHAEL J BROWN
Correspondent
Medovations, Inc.
1294 Barclay Blvd.
Buffalo Grove,  IL  60089
Correspondent Contact MICHAEL J BROWN
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received08/03/2000
Decision Date 11/01/2000
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
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