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FDA 510(k) Application Details - K012259
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K012259
Device Name
Accessories, Pump, Infusion
Applicant
NATIONAL CUSTOM ENT., INC.
1133 EAST CLIFF RD.
BURNSVILLE, MN 55337 US
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Contact
DON PELLETIER
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2001
Decision Date
09/12/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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