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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
Predetermined Change
Control Plan Authorized		 No
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