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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 K151777
FOIA Releasable 510(k) K151777
Device Name Intradermal Adapter
Applicant
West Pharmaceutical Services, Inc.
530 Herman O W. Dr.
Exton,  PA  19341
Applicant Contact JEFFREY RAVEL
Correspondent
West Pharmaceutical Services, Inc.
530 Herman O W. Dr.
Exton,  PA  19341
Correspondent Contact JEFFREY RAVEL
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/01/2015
Decision Date 09/29/2015
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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