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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 K033794
Device Name ULTICARE DISPOSABLE SYRINGE 3 ML/CC
Applicant
ULTIMED, INC.
188 SUQUAMISH WAY
LACONNER,  WA  98257
Applicant Contact ELLEN G REDDING
Correspondent
ULTIMED, INC.
188 SUQUAMISH WAY
LACONNER,  WA  98257
Correspondent Contact ELLEN G REDDING
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/05/2003
Decision Date 12/30/2003
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
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