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FDA 510(k) Application Details - K030165
Device Classification Name
System, Telethermographic (Adjunctive Use)
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510(K) Number
K030165
Device Name
System, Telethermographic (Adjunctive Use)
Applicant
THERMATREK
660 MAIN ST., SOUTH, #7
WOODBURY, CT 06798 US
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Contact
DAVID R BALZER
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Regulation Number
884.2980
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Classification Product Code
LHQ
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More FDA Info for this Product Code
Date Received
01/16/2003
Decision Date
04/16/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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