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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K890786
Device Name IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PEGGY WALLINE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/15/1989
Decision Date 07/28/1989
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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