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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 K980378
Device Name MELODIE INFUSION PUMP
Applicant
Compagnie DE Developpement Aguettant
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact DIANE MCCOLL
Correspondent
Compagnie DE Developpement Aguettant
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact DIANE MCCOLL
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/30/1998
Decision Date 12/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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