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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 K023907
Device Name CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
Applicant
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Applicant Contact DONNA MARSHALL
Correspondent
CORDIS CORP.
7 POWDER HORN DR.
WARREN,  NJ  07059
Correspondent Contact DONNA MARSHALL
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received11/25/2002
Decision Date 12/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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