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FDA 510(k) Application Details - K060123
Device Classification Name
Monitor, Electric For Gravity Flow Infusion Systems
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510(K) Number
K060123
Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact
JANICE HASELTON
Other 510(k) Applications for this Contact
Regulation Number
880.2420
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Classification Product Code
FLN
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More FDA Info for this Product Code
Date Received
01/18/2006
Decision Date
02/14/2006
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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