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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 K860595
Device Name TRANSFER SET
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
LHI  
Date Received02/19/1986
Decision Date 04/07/1986
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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