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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 K043605
Device Name INSCOPE 3-STAGE BALLOON DILATOR
Applicant
Cordis Europa, N.V.
Oosteinde 8
Roden, Drenthe,  NL NL-9301 LJ
Applicant Contact HARM HOVINGA
Correspondent
Cordis Europa, N.V.
Oosteinde 8
Roden, Drenthe,  NL NL-9301 LJ
Correspondent Contact HARM HOVINGA
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received12/30/2004
Decision Date 02/04/2005
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
Predetermined Change
Control Plan Authorized		 No
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