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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 K123588
Device Name INTRADERMAL ADAPTER
Applicant
West Pharmaceutical Services, Inc.
101 Gordon Dr.
Lionville,  PA  19341
Applicant Contact DEBBIE M THOMAS
Correspondent
West Pharmaceutical Services, Inc.
101 Gordon Dr.
Lionville,  PA  19341
Correspondent Contact DEBBIE M THOMAS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/21/2012
Decision Date 02/19/2013
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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