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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessories, catheter, g-u
510(k) Number K951488
Device Name KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
Original Applicant
THE KENDAL CO.
15 hampshire st.
mansfield,  MA  02048 -1108
Original Contact paul w evans
Regulation Number876.5130
Classification Product Code
KNY  
Date Received03/31/1995
Decision Date 04/25/1995
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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