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FDA 510(k) Application Details - K123776
Device Classification Name
Lamp, Surgical
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510(K) Number
K123776
Device Name
Lamp, Surgical
Applicant
DRAGER MEDICAL GMBH
6 TECH DRIVE
ANDOVER, MA 01810 US
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Contact
BETH ZIS
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FTD
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More FDA Info for this Product Code
Date Received
12/10/2012
Decision Date
03/08/2013
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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