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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 E. Arbrook Blvd.
Arlington,  TX  76014 -3631
Applicant Contact LINDA G HILL
Correspondent
Johnson & Johnson Medical, Div. of Ethicon, Inc.
2500 E. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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