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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K840411
Device Name BLOOD & PLASMA ADMIN. DEV-STERILE
Applicant
Loversan
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Loversan
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received01/31/1984
Decision Date 03/19/1984
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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