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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 K930459
Device Name BARD MINI-INFUSER 1500 & 3000
Applicant
Bard Medsystems Div.
87 Concord St.
North Reading,  MA  01864
Applicant Contact BRUCE W HUSEL
Correspondent
Bard Medsystems Div.
87 Concord St.
North Reading,  MA  01864
Correspondent Contact BRUCE W HUSEL
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/28/1993
Decision Date 08/10/1993
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
Recalls CDRH Recalls
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