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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 K083583
Device Name XPRESSE INJECTION SYSTEM
Applicant
Nordson Efd
40 Catamore Blvd.
East Providence,  RI  02914
Applicant Contact JEFF PEMBROKE
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/04/2008
Decision Date 06/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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