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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K881667
Device Name KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH
Applicant
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Applicant Contact JANE R ARNOLD
Correspondent
THE KENDAL CO.
ONE FEDERAL ST.
BOSTON,  MA  02110 -2003
Correspondent Contact JANE R ARNOLD
Regulation Number876.5130
Classification Product Code
GBM  
Date Received04/18/1988
Decision Date 08/12/1988
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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