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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K984060
Device Name LUER ACCESS INJECTION SITE
Applicant
Baxter Healthcare Corp
Clintec Nutrition Co.
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact MARY ELLEN SNYDER
Correspondent
Baxter Healthcare Corp
Clintec Nutrition Co.
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact MARY ELLEN SNYDER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/13/1998
Decision Date 07/26/1999
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
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