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
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Regulation Number 878.4580

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Classification Product Code FTD
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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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