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FDA 510(k) Application Details - K051474
Device Classification Name
Pump, Infusion, Elastomeric
More FDA Info for this Device
510(K) Number
K051474
Device Name
Pump, Infusion, Elastomeric
Applicant
SYMBIOS MEDICAL PRODUCTS, LLC
6131 WEST 80TH STREET
INDIANAPOLIS, IN 46278-1344 US
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Contact
JEFFERY J ALHOLM
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
06/03/2005
Decision Date
07/01/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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