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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K922214
Device Name EMPTY VIAFLEX PLASTIC CONTAINER
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact MARCIA MARCONI
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact MARCIA MARCONI
Regulation Number880.5025
Classification Product Code
KPE  
Date Received05/12/1992
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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