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FDA 510(k) Application Details - K042906
Device Classification Name
Thermometer, Electronic, Clinical
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510(K) Number
K042906
Device Name
Thermometer, Electronic, Clinical
Applicant
AMPLIFE CORPORATION
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
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
10/21/2004
Decision Date
11/19/2004
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
Y
Expedited Review
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