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FDA 510(k) Application Details - K994375
Device Classification Name
Pump, Infusion
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510(K) Number
K994375
Device Name
Pump, Infusion
Applicant
B. BRAUN MEDICAL, INC.
1601 WALLACE DR., SUITE 150
CARROLLTON, TX 75006 US
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Contact
GARY GULYAS
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Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
12/27/1999
Decision Date
03/08/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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