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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 K830780
Device Name KOALA C99 I.V. CONTROLLER
Applicant
CHESEBROUGH-POND'S U.S.A. CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CHESEBROUGH-POND'S U.S.A. CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5725
Classification Product Code
LDR  
Date Received03/11/1983
Decision Date 04/08/1983
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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