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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 K982020
Device Name METRON QA-IDS I.V. PUMP TESTER
Applicant
Metron U.S., Inc.
P.O. Box 4341
Crofton,  MD  21114 -4341
Applicant Contact E.J. Smith
Correspondent
Metron U.S., Inc.
P.O. Box 4341
Crofton,  MD  21114 -4341
Correspondent Contact E.J. Smith
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/09/1998
Decision Date 09/30/1998
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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