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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 K990236
Device Name MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
Applicant
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
2500 EAST ARBROOK BLVD.
ARLINGTON,  TX  76014 -3631
Applicant Contact LINDA G HILL
Correspondent
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
2500 EAST ARBROOK BLVD.
ARLINGTON,  TX  76014 -3631
Correspondent Contact LINDA G HILL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/25/1999
Decision Date 08/20/1999
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
Recalls CDRH Recalls
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