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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, Pca
510(k) Number K092313
Device Name PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
Applicant
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact SUSAN OLINGER
Correspondent
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact Tracy Maddock
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
FRN  
Date Received07/30/2009
Decision Date 11/04/2009
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
Recalls CDRH Recalls
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