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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 K934561
Device Name ONE TIME VIAL ACCESS SPIKE
Applicant
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Applicant Contact SALVADORE F PALMARES
Correspondent
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Correspondent Contact SALVADORE F PALMARES
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/21/1993
Decision Date 02/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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