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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K910546
Device Name PIGGY LOCK NEEDLE HOUSING
Applicant
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Applicant Contact ARACELI C FANCHER
Correspondent
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Correspondent Contact ARACELI C FANCHER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/06/1991
Decision Date 04/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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