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FDA 510(k) Application Details - K962991
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K962991
Device Name
Thermometer, Electronic, Clinical
Applicant
POLYMEDICA INDUSTRIES, INC.
581 CONFERENCE PL.
GOLDEN, CO 80401 US
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Contact
JULIE CHAFFEE
Other 510(k) Applications for this Contact
Regulation Number
880.2910
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Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/1996
Decision Date
09/12/1996
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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