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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion
510(k) Number K884014
Device Name FLO-GARD VP
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Applicant Contact NANCY E SHADFORTH
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 11150
SANTA ANA,  CA  92711
Correspondent Contact NANCY E SHADFORTH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/22/1988
Decision Date 12/12/1988
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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