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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 K092986
Device Name ACACIA PISTON SYRINGE
Applicant
ACACIA, INC.
785 CHALLENGER STREET
BREA,  CA  92821
Applicant Contact FERGIE FERGUSON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/28/2009
Decision Date 10/27/2009
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
Recalls CDRH Recalls
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