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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 K101940
Device Name EQUASHIELD SYSTEM PROTECTIVE PLUS
Applicant
Equashield Medical , Ltd.
Tefen Industrial Park
P.O. B 12
Migdal,  IL 24959
Applicant Contact ELISSA BURG
Correspondent
Equashield Medical , Ltd.
Tefen Industrial Park
P.O. B 12
Migdal,  IL 24959
Correspondent Contact ELISSA BURG
Regulation Number880.5440
Classification Product Code
LHI  
Date Received07/12/2010
Decision Date 11/19/2010
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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