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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 K850674
Device Name CORMED II AMBULATORY INFUSION PUMP
Applicant
CORMED, INC., SUB. C.R.BARD, INC.
591 MAHAR ST.
MEDINA,  NY  14103
Applicant Contact THURMAN S JESS
Correspondent
CORMED, INC., SUB. C.R.BARD, INC.
591 MAHAR ST.
MEDINA,  NY  14103
Correspondent Contact THURMAN S JESS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/20/1985
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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