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FDA 510(k) Application Details - K010724
Device Classification Name
Lamp, Surgical
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510(K) Number
K010724
Device Name
Lamp, Surgical
Applicant
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD, PA 18969 US
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Contact
JAMES J BRENNAN
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
03/12/2001
Decision Date
06/07/2001
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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