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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K843954
Device Name MIXING CONTAINER
Applicant
American Mcgaw
P.O. Box 1187
Santa Ana,  CA  92711
Applicant Contact FLOYD BENJAMIN
Correspondent
American Mcgaw
P.O. Box 1187
Santa Ana,  CA  92711
Correspondent Contact FLOYD BENJAMIN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received10/09/1984
Decision Date 11/28/1984
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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