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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
Applicant Contact MARY E SNYDER
Correspondent
Baxter Healthcare Corp
P.O. Box 490 Rt. 120 And
Wilson Rd.
Round Lake,  IL  60073
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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