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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K000087
Device Name MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
Applicant
THE KENDAL CO.
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048 -1108
Applicant Contact REGINA YEH
Correspondent
THE KENDAL CO.
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048 -1108
Correspondent Contact REGINA YEH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/12/2000
Decision Date 03/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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