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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 K900585
Device Name TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
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 Received02/07/1990
Decision Date 04/18/1990
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
Recalls CDRH Recalls
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