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FDA 510(k) Application Details - K003611
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K003611
Device Name
Pump, Infusion
Applicant
BREG, INC.
2611 COMMERCE WAY
VISTA, CA 92083 US
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Contact
KATHLEEN BARBER
Other 510(k) Applications for this Contact
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
11/22/2000
Decision Date
12/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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