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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(k) Number K141448
Device Name TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
Applicant
Teva Medical Ltd., Migada Plant
Piazza Albania 10
Rome,  IT 00153
Applicant Contact ROGER L GRAY
Correspondent
Teva Medical Ltd., Migada Plant
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact ROGER L GRAY
Regulation Number880.5440
Classification Product Code
ONB  
Date Received06/02/2014
Decision Date 01/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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