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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K882167
Device Name IVY COMMANDER, MODEL 600
Applicant
IVY MEDICAL, INC.
7411 WASHINGTON AVENUE SOUTH
MINNEAPOLIS,  MN  55435
Applicant Contact STEPHEN A LEVIE
Correspondent
IVY MEDICAL, INC.
7411 WASHINGTON AVENUE SOUTH
MINNEAPOLIS,  MN  55435
Correspondent Contact STEPHEN A LEVIE
Regulation Number880.5725
Classification Product Code
LDR  
Date Received05/24/1988
Decision Date 09/23/1988
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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