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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 K904225
Device Name KWIKMIX
Applicant
BAXA CORP., SUB. OF COOK GROUP, INC.
13760 E. ARAPAHOE RD.
ENGLEWOOD,  CO  80112
Applicant Contact MARY STEGGALL
Correspondent
BAXA CORP., SUB. OF COOK GROUP, INC.
13760 E. ARAPAHOE RD.
ENGLEWOOD,  CO  80112
Correspondent Contact MARY STEGGALL
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/13/1990
Decision Date 11/05/1990
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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