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FDA 510(k) Application Details - K061409
Device Classification Name
Pump, Infusion, Elastomeric
More FDA Info for this Device
510(K) Number
K061409
Device Name
Pump, Infusion, Elastomeric
Applicant
PRECISE MEDICAL PRODUCTS, LTD.
DORA ST. (INDUSTRIAL ZONE)
SHLOMI 22832 IL
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Contact
OFER SHAY
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2006
Decision Date
06/16/2006
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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