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FDA 510(k) Application Details - K060537
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K060537
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
ENGINIVITY LLC
8 GRAY LODGE ROAD
KITTERY, ME 03904 US
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Contact
PENELOPE GRECO
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Regulation Number
000.0000
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Classification Product Code
LGZ
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More FDA Info for this Product Code
Date Received
02/28/2006
Decision Date
06/08/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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