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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 K945053
Device Name LF CT HIG PRESSURE CATHETERS
Applicant
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Applicant Contact M L FRIEDMAN
Correspondent
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Correspondent Contact M L FRIEDMAN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/14/1994
Decision Date 05/19/1995
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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