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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 K981318
FOIA Releasable 510(k) K981318
Device Name DUAL LUER LOCK CAP
Applicant
Baxter Healthcare Corp
Rt. 120 & Wilson Rd.
Round Lake,  IL  60073
Applicant Contact MARY ELLEN SNYDER
Correspondent
Baxter Healthcare Corp
Rt. 120 & Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact MARY ELLEN SNYDER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/10/1998
Decision Date 04/22/1998
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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