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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 K904619
Device Name INFU.DISK
Applicant
Electrochemical Drug Delivery, Inc.
10633 Roselle
Suite E
San Diego,  CA  92121
Applicant Contact CONI ROSATI
Correspondent
Electrochemical Drug Delivery, Inc.
10633 Roselle
Suite E
San Diego,  CA  92121
Correspondent Contact CONI ROSATI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/11/1990
Decision Date 11/05/1991
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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