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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K935630
Device Name NORTA
Applicant
BEIERSDORF, INC.
360 MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856
Applicant Contact KENNETH M NICOLL
Correspondent
BEIERSDORF, INC.
360 MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856
Correspondent Contact KENNETH M NICOLL
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/23/1993
Decision Date 10/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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