FDA 510(k) Application Details - K993314

Device Classification Name Lamp, Operating-Room

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510(K) Number K993314
Device Name Lamp, Operating-Room
Applicant SYNTHES (USA)
1303 GOSHEN PKWY.
WAST CHESTER, PA 19380 US
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Contact JONATHAN GILBERT
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Regulation Number 878.4580

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Classification Product Code FQP
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Date Received 10/04/1999
Decision Date 12/06/1999
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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