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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 K844904
Device Name CYTOSAFE NEEDLE
Applicant
Baxa Corp., Sub. of Cook Group, Inc.
P.O. Box 9327
Denver,  CO  80209
Applicant Contact MARY STEGGALL
Correspondent
Baxa Corp., Sub. of Cook Group, Inc.
P.O. Box 9327
Denver,  CO  80209
Correspondent Contact MARY STEGGALL
Regulation Number880.5440
Classification Product Code
LHI  
Date Received12/17/1984
Decision Date 02/22/1985
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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