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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 K970438
Device Name INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 490 RT. 120 AND
WILSON RD.
ROUND LAKE,  IL  60073 -0490
Applicant Contact MARY E SNYDER
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 490 RT. 120 AND
WILSON RD.
ROUND LAKE,  IL  60073 -0490
Correspondent Contact MARY E SNYDER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/05/1997
Decision Date 04/02/1997
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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