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FDA 510(k) Application Details - K020988
Device Classification Name
Pump, Infusion, Elastomeric
More FDA Info for this Device
510(K) Number
K020988
Device Name
Pump, Infusion, Elastomeric
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
MEB
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More FDA Info for this Product Code
Date Received
03/27/2002
Decision Date
04/04/2002
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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