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FDA 510(k) Application Details - K013242
Device Classification Name
Lamp, Surgical
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510(K) Number
K013242
Device Name
Lamp, Surgical
Applicant
STERIS Corporation
2720 GUNTER PARK EAST
MONTGOMERY, AL 36109 US
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Contact
ROBERT H MCCALL
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Regulation Number
878.4580
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Classification Product Code
FTD
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Date Received
09/28/2001
Decision Date
12/13/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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