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FDA 510(k) Application Details - K992386
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K992386
Device Name
System, Thermal Regulating
Applicant
MTRE ADVANCED TECHNOLOGY LTD.
117 AHUZAH ST
RAANANNA 43373 IL
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Contact
SHOSHANA FRIEDMAN
Other 510(k) Applications for this Contact
Regulation Number
870.5900
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Classification Product Code
DWJ
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More FDA Info for this Product Code
Date Received
07/16/1999
Decision Date
03/07/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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