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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 K061937
Device Name COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
Applicant
COOK ENDOSCOPY
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact MABEL L HUNTER
Correspondent
COOK ENDOSCOPY
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact MABEL L HUNTER
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received07/10/2006
Decision Date 12/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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