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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K141245
Device Name ETEX MIXING AND DELIVERY SYSTEM
Applicant
Etex Corporation
675 Massachusetts Ave.
12th Floor
Cambridge,  MA  02139
Applicant Contact ANDY SOMAN
Correspondent
Etex Corporation
675 Massachusetts Ave.
12th Floor
Cambridge,  MA  02139
Correspondent Contact ANDY SOMAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/14/2014
Decision Date 07/09/2014
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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