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FDA 510(k) Application Details - K121775
Device Classification Name
Warmer, Thermal, Infusion Fluid
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510(K) Number
K121775
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
20 CAMPUS RD
TOTOWA, NJ 07512 US
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Contact
STACIE GEFFNER-ATIYA
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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
06/18/2012
Decision Date
11/28/2012
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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