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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, Pca
510(k) Number K910257
Device Name BAXA PCA INFUSOR
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 Number880.5725
Classification Product Code
MEA  
Date Received01/22/1991
Decision Date 11/07/1991
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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