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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, i.v. fluid transfer
510(k) Number K924064
Device Name INTERLINK UNIVERSAL VIAL ADAPTER
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact MARCIA MARCONI
Correspondent
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact MARCIA MARCONI
Regulation Number880.5440
Classification Product Code
LHI  
Date Received08/12/1992
Decision Date 04/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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