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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 K994230
Device Name ULTICARE DISPOSABLE SYRINGE
Applicant
ULTIMED, INC.
287 EAST 6TH ST.
ST. PAUL,  MN  55101
Applicant Contact CHARLES W ERICKSON
Correspondent
ULTIMED, INC.
287 EAST 6TH ST.
ST. PAUL,  MN  55101
Correspondent Contact CHARLES W ERICKSON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/16/1999
Decision Date 03/24/2000
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
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