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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 K150219
FOIA Releasable 510(k) K150219
Device Name Equashield Closed System drug Transfer Device (CSTD)
Applicant
Equashield Medical , Ltd.
Tefen Industrial Park
P.O. B 12
Migdal,  IL 24959
Applicant Contact Raymond J Kelly
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact Raymond J Kelly IV
Regulation Number880.5440
Classification Product Code
ONB  
Date Received01/30/2015
Decision Date 11/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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