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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 K943095
Device Name IV TRANSFER SPIKE
Applicant
Migada, Ltd.
P.O. Box 888
Kiryat Shmona,  IL 10258
Applicant Contact ZVI LEVINHAR
Correspondent
Migada, Ltd.
P.O. Box 888
Kiryat Shmona,  IL 10258
Correspondent Contact ZVI LEVINHAR
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/28/1994
Decision Date 09/30/1994
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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