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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 K850653
Device Name IMED 440 INFUSION PUMP & ADMINISTRATION SET
Applicant
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131 -1699
Applicant Contact RALPH H JARBOE
Correspondent
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131 -1699
Correspondent Contact RALPH H JARBOE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/19/1985
Decision Date 04/09/1985
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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