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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 K895797
Device Name IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
Applicant
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131 -1699
Applicant Contact JARBOE, PHD
Correspondent
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131 -1699
Correspondent Contact JARBOE, PHD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/28/1989
Decision Date 01/02/1990
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
Recalls CDRH Recalls
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