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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 K051669
Device Name TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
Applicant
MIGADA PLANT
PO BOX 888
KIRYAT SHMONA,  IL 10258
Applicant Contact YOSSI SHACHAR
Correspondent
MIGADA PLANT
PO BOX 888
KIRYAT SHMONA,  IL 10258
Correspondent Contact YOSSI SHACHAR
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/22/2005
Decision Date 09/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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