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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
Predetermined Change
Control Plan Authorized		 No
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