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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 K853386
Device Name MULTISET 40
Applicant
Migada, Ltd.
P.O. Box 2 Ashdod
77100
Israel,  IL
Applicant Contact DAVID THALER
Correspondent
Migada, Ltd.
P.O. Box 2 Ashdod
77100
Israel,  IL
Correspondent Contact DAVID THALER
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received08/12/1985
Decision Date 08/22/1985
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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