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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K163511
Device Name NovaGuard SA Pro Safety System
Applicant
West Pharmaceutical Services, Inc.
530 Herman O. W. Dr.
Exton,  PA  19341
Applicant Contact Ana Ladino
Correspondent
West Pharmaceutical Services, Inc.
530 Herman O. W. Dr.
Exton,  PA  19341
Correspondent Contact Ana Ladino
Regulation Number880.5860
Classification Product Code
MEG  
Date Received12/15/2016
Decision Date 02/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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