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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 K980493
Device Name I.V. CATHETER SYSTEM
Applicant
Johnson & Johnson Medical, Inc.
2500 Arbrook Blvd.
P.O. Box 90130
Arlington,  TX  76004
Applicant Contact LINDA G HILL
Correspondent
Johnson & Johnson Medical, Inc.
2500 Arbrook Blvd.
P.O. Box 90130
Arlington,  TX  76004
Correspondent Contact LINDA G HILL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/09/1998
Decision Date 04/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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