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FDA 510(k) Application Details - K954792
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K954792
Device Name
Thermometer, Electronic, Clinical
Applicant
LUMISCOPE CO., INC.
400 RARITAN CENTER PKWY.
EDISON, NJ 08837 US
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Contact
THOMAS C PARNELL
Other 510(k) Applications for this Contact
Regulation Number
880.2910
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Classification Product Code
FLL
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More FDA Info for this Product Code
Date Received
10/18/1995
Decision Date
06/21/1996
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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