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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 K842263
Device Name MTP E.V. INFUSION PUMP
Applicant
Ziehm International, Inc.
2012 Renard Ct., Unit A & D
Annapolis,  MD  21401
Correspondent
Ziehm International, Inc.
2012 Renard Ct., Unit A & D
Annapolis,  MD  21401
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/07/1984
Decision Date 07/25/1984
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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