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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 K983005
Device Name PERFUSOR COMPACT
Applicant
B.Braun Medical, Inc.
1601 Wallace Dr., Suite 150
Carrollton,  TX  75006
Applicant Contact GARY A GULYAS
Correspondent
B.Braun Medical, Inc.
1601 Wallace Dr., Suite 150
Carrollton,  TX  75006
Correspondent Contact GARY A GULYAS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/28/1998
Decision Date 02/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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