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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 K170706
Device Name Equashield Closed System drug Transfer Device (CSTD)
Applicant
Equashield Medical , Ltd.
Tefen Industrial Park
Migdal Tefen,  IL 24959
Applicant Contact Dorit Valal
Correspondent
Licensale, Inc.
68 Southwoods Ter.
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
ONB  
Date Received03/08/2017
Decision Date 07/03/2017
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
Predetermined Change
Control Plan Authorized		 No
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