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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K872743
Device Name BAXA TUBING SETS (FOR 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 Number880.5860
Classification Product Code
FMF  
Date Received07/13/1987
Decision Date 10/09/1987
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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